ASR Articular Surface Replacement Risk Evaluation

SEP 112-2 Rev A
Health Hazard/Risk Evaluation
HHE Coordinator: Jens Krugmann
Product Data
Product Name : DePuy ASR" Articular Surface Replacement (Not approved for use in the US) and ASRT"' X Metal-on-Metal System Monoblock
Product Codes Affected
Lot NumberslSerial
Numbers (As known)
Quantity (As known)
See attached All
Finished Goods
Distributor
Sold
Approx. 98,000 systems
Manufacturer: (If external include Name and Contact Information) DePuy International, Ltd. St. Anthony's Road Leeds LS 11 8DT
Page 1 of 13
PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER.
DEPUY000291920
SEP 112-2 Rev A

Complaint, Incident, Problem Reported: Attachments: 1, 2. Complaints Review NJR - HESIPEDW Linked Dataset for ASR Hip Resurfacing
Following our previous HHE conducted on 8th January 2010 our ongoing Post Market Surveillance Activities have identified additional data that is being considered as part of this health hazard evaluation (see attachments). Previous HHE conducted on 8t" January 2010 suggested a higher than expected revision rate for the DePuy ASRThd Articular Surface Replacement and ASR XL Monoblock Metal-on-Metal (MUM) System linked to usage of monoblock MoM cups with corresponding head sizes below 50 mm in diameter based on the analysis of various datasets (joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports). The Australian National Joint Replacement Registry had reported a cumulative percentage revision rate of 5.4% at 3 years for the ASR Cup and XL head used with DePuy stems in total hip replacement. At that time recent published and unpublished data suggested that this rate may be higher in cohorts where a large proportion is female or has small acetabulae. These data suggested that smaller heads (less than 50 mm diameter) are associated with a higher rate of revision (up to 8-9 % at three years). While the analysis conducted at that time did not demonstrate conclusive findings regarding the relationship between gender and implant head size, DePuy believed that the analysis of the collective dataset provided reasons to take special care in patient selection and cup placement when choosing to use the DePuy ASR TM Articular Surface Replacement and ASR XL Monoblock Metal-on-Metal System with head sizes below 50 mm, (cup sizes 56 mm and smaller). This data was consistent with other published data for the use of the DePuy ASR monoblock metal-on-metal resurfacing system and other similar devices in the class. Following the former HHE, actions recommended by the HHE Committee were taken to provide a Dear Doctor letter to previous and current users of the ASR platform to inform them of our recent analysis of datasets from various sources and remind them on several aspects in order to achieve optimal implant performance and survivorship (please see HEALTH HAZARD/RISK EVALUATION EXECUTIVE REVIEW BOARD: Complaint No. 12725 - DePuy ASRTW Articular Surface Replacement and ASR XL Monoblock Metal-on-Metal (MoM) System, which was signed off on 19e" April 2010 ). New information has become available which suggests a revision rate of 12.0% at 5 years for ASR cups with ASR femoral components (NJR - HES/PEDW Linked Dataset for ASR Hip Resurfacing) while the class' revision rate is 6.0%. For a similar population the reported 3-year revision rate for ASR cups with ASR femoral components of 6.9% compared to 4.2% of the class. From former data it is not expected that the 5-year revision rate for ASR cups with ASR XL modular heads will be significantly lower.
Number of Complaints , Incidents , Problems Reported:

See attached complaints review and NJR - HES/PEDW Linked Dataset for ASR Hip Resurfacing
Number of Injuries : As above Source of Reports: Hos pital u X
Number of Deaths: 0 Patient u uePU /J&J Affiliate or Distributor
Complaint No.: Ref. HHE DINT 12725
Page 2 of 13
DEPUY000291921
SEP 112-2 RevA
ll.
Health Hazard/Risk Evaluation Problem Definition and Analysis
Product Description : ( A description of the product and its intended use) The DePuy ASRT^^ Articular Surface Replacement and ASRT"' XL Monoblock Metal-on-Metal System are high performance metal-on-metal bearings designed and manufactured within fine tolerances to facilitate a state of fluid film lubrication. The system is designed to reduce wear and provide high function for all patients. The ASR platform consists of the following: Hip Surface Replacement ( Not approved for use in the US) - ASRTM Surface Replacement Head - Monoblock ASR T" Acetabular Cup Total Hip Replacement- ASR TM XL Modular Head - Monoblock ASRTM Acetabular Cup Description of the hazard/risk caused by the product issue ( Defect/Malfunction or Error in Use): Early revision of the prosthesis due to loosening or adverse tissue reaction.
Device or Other Product Related Factors Possibly Contributing to the Health Hazard /Risk Situation: The DePuy ASRT"^ Articular Surface Replacement and ASRT^" XL Monoblock Metal-on-Metal System is recognized to be in a class to have a more challenging implantation technique than conventional total hip replacement. Reasons for revision identified within the datasets are typical for the class of large diameter MoM monoblock cups and includes component loosening, component malalignment, infection, pain, fracture, dislocation and metal sensitivity.
Use Related , User or Human Performance Contributing Factors:
As above
Population at Greater Risk: (e . g., children , elderly, pregnant women , immune deficient patients, etc.)
Potential greater risk for cohorts where a large proportion is female or has small acetabulae for ASR as well as for devices throughout the class. No evidence that a specific population group is at greater risk attributed to the application of ASR when compared to class.
immediate and/or Long Range Consequences of the Health Hazard /Risk (specify):
The immediate consequence of cup loosening or adverse tissue reaction is the necessity for revision surgery to reverse impairment. Successful revision surgery will obviate any long range consequences.
aint No.: RefHHE dated 15 September, 2008
Page 3 of 13
DEPUY000291922
SEP 112-2 Rev A

Ill.HealthlRisk Index
Likelihood of Occurrence of the Product Issue
Remote Rare Occasional Frequent Continuously Occurring
Circles the appra- late value Comments: 0 The product issue is defined as early revision of the prosthesis due to loosening or adverse tissue reaction. +1 The available data suggests an increase in revision rates for ASR cups with ASR femoral components at 5 years. +2 Reference attached NJR - HES/PEDW Linked Dataset for ASR Hip Resurfacing. Although the revision rate has increased the HHE Committee considers a "frequent" rate marked as "3" as still appropriate.
Probability of the Product Issue resulting in Health Hazard t

Extremely Unlikely Unlikely but Possible Likely Very Likely Extremely Likely +4 0 +1 +2
Comments: The probability of the product issue (defined as early revision of the prosthesis due to loosening or adverse tissue reaction) resulting in a health hazard or risk is considered "very likely".
Severity of the Heal h HazardlRisk

None (No adverse Health Consequences) Limited (Transient, Self-limiting Illness or injury Moderate (Significant Impairment, but temporary/reve rsible) Sever (Serious Injury, Permanent Impairment, Irreversible) Life Threat ( Life threatening , Death Could Occur) Comments: The immediate consequence of cup loosening or adverse tissue reaction is the necessity for revision surgery to +1 reverse impairment. Successful revision surgery is expected to obviate any long range consequences. As with all revision surgery there are associated risks, in isolated +9 cases permanent impairment could occur related to adverse reactions to metal debris.
+3 +4
Hazard/Risk Index
(Obtained by adding the scores of the above three sections
ilnctlcate score in line RZarO/N{SK lrm eX l3OX}
NonefNegligible/Broadly Acceptable Low/As Low As Reasonably Practicable (ALARP)
0-3 4-6 7-9 10-12 I
Moderate/Undesirable
High/Unacceptable
Comments: Revision rates are higher than the class and higher than those for conventional total hip replacement surgeries where the PinnacleTM cup is used. Although the revision rate has increased the HHE Committee considers a "HazardJRisk index" of "8" as still appropriate. However, additional actions were determined as I necessary.
Hazard/Risk Index If Index is > 7, Field Action has to be considered
Complaint No.: Ref. HHE dated 15 September, 2008
Page 4 of 13
DEPUY000291923
112-2 Rev A
Health Hazard/Risk Evaluation IV Recommendation

The HHE Committee recommend:
No further action is required , complete Corrective and Preventative Action
based on review of failure investigation and close file.

(Document Rational)
X u
Board level review of this issue and consideration of field action.

(Attachment C is required)
The action recommended by the HHE Committee is to recall the distributed product from all markets a nd establish a strategy for making products available, if necessary, for compassionate use.
Health Hazard/Risk Evaluation Committee

) (Please Print and Sign .your Name Complaint Manager :---Date: ^:.
Quality Systems Manager
Date:
Product Development Engineer
Date:
Operations ManagerfBU Manager

(Where applicable) Marketing Manager (Where Applicable)C ^^.
Date:
Date: Date: Date:
Medical Professional
(Required for Health Risk Evaluation not submitted to the board)
Other
Approval ....
The HHE Committee Recommendation is (Check _Appropriate Box] Director Quality Systems * 11 v/ Approved El Reject Date:
WW VP Quality Systems * *
Date:
Director Regulatory
Date:
Or Nominated Deputy Attachments: Complaints Review NJR - HES/PEDW Linked Dataset for ASR Hip Resurfacing
Page 5 of 13
DEPUY000291924
SE P 1 12-2 Rev A
Health Hazard/Risk Evaluation W :Recomm endation

The HHE Committee recommend: I No further action is required , complete Corrective and Preventative Action based on review of failure investigation and close file.
(Document Rational)
Board level review of this issue and consideration of field action. (Attachment Cis required)
Tho action recommended by the I-IHE Committee i s to recall the distributed product from all markets and establish a strategy for making products available , if necessary, for compassionate use.
Health Hazard/Risk Evaluation Committee E'Eease Print ancf Sign your Namc
Complaint Manager
Quality Systems Manager Date:
Date:
Product Development Engineer
Date:
Operations Manager113UJ Manager (Where applicable) Marketing Manager (Whore Applicable) Medical Professional (Required for Health Risk Evaluation not submitted to the board)
Date:
Date:
Other
Approval
The HHE Committee Recommendation is (Check Appropriate Box) Director Quality Systems * 1::1 Approved I[.] Reject
-----____.- ......_......... Dato:
WW VP Quality Systems
Date:
Director Regu latory ^,-
1 Date:
Or Nominated Deputy Attaciarnents: Compaints Review NJR - I-IES/PEDW I_inkoci Datasot for ASR Hip Resurfacing
Pape 5 of 13
DEPUY000291925
SEP 112-2 Rev A
Health Hazard/Risk Evaluation IV. Recom m en d ation
L--1
No further action is required, complete Corrective and Preventative Action based on review of failure investigation and close file.
(Document Rational)
Board level review of this issue and consideration of field action. (Attachment C is required)
The action recommended by the HHE Committee is to recall the distributed product from all markets and establish a strategy for making products availab#e, if necessary, for compassionate use.
Health Hazard/Rick
Please Pt'itlt and,Sign your Name Complaint Manager
Evaluation
Committee
Operations Manager/BU Manager (Where applicable)
Marketing Manager (Whore Applicable)
Other
The HHE Committee Recommendation is (Check Appropriat(j l3ox)__..__ -.-Director Quality Systems
C Date_^^.
WW VP Quality Systems
Date:
Director Regulatory
Date:
* Or Nominated Deputy Attachments: Complaints Review

NJR - I-{ES/PEDW Linked Dataset for ASR I-tip Resurfacing
Pago 5 01 13
PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER .
DEPUY000291926
SEP'112-2 RevA
Health Hazard/Risk Ev U Ce i9 a n W. Reco mmendation

The HHE Committee recommend: El No furth er action is required , complete Corrective and Preventative Action based on review o f failure investigation and close tile(Docurnent Rational)
}C
Board level review of this issue and consideration of field action.

The action recommended by the 1-II-lE Committee is to recall the distributed product from all markets and establish a stratocly for making products available , if necessary , for compassionate use.

Please Print and Sigour Name) Complaint Manager
Late:
Date:
Product Development F_ngineer
Date:
Operations ManagerfBU Manager

(Where Applicable)
Date:
Late
Marketing Manager
(Whore Applicable) Medical Professional
(fie aired f r I ealth Risk Evaluation not submitted to the b oar d )
__
D ate ^
`. "
.Xi
r to
Other
Date:
The HHE Committee Recommendation is
Approved
Reject
(Check Appropriate Box Director Quality Systems *
Date:
WW VP Quality Systems *
Date:
Director Regulatory
Date:
* Or Nominated Deputy
Attachments: Complaints Review

N,JR - HES/I'EDW Linked Dataset for ASP Hip Resurfacing
Page 3of13
DEPUY000291927
SEP 112-2 Rev A
Health Hazard/Risk Evaluation IV. Recommendation

The HHE Committee recommend: (^ No further action is required, complete Corrective and Preventative Action t ^l based on review of failure investigation and close file.
(Document Rational)
Board level review of this issue and consideration of field action. (Attachment Cis required)
The action recommended by the I- HE Committee is to recall the distributed product from all markets and establish a strategy for making products available, if necessary , for compassionate use.

(Please Print and;5r.n yqul Name Complaint Manager f
Quality Systerns Manager Date:
Date:
Product Development Enghi er

(_ 11^-\ .\. 111\ \t
Date:
Operations Manager/BU Manager (Where applicable) Marketing Manager (Where Applicable)
Date:
Date:
(Required for Health Risk Evaluation not subrnitted to the board)
Date:
Date: -
Other
I
-Approval
The t-IHE Committee Recommendation is -.(Check Appropriate Box) Director Quality Systems ['.IV Approved CI Reject
Date:
Date:
1 Director Regulatory
Date;
Or Nominated Deputy
AttachmontS: Complaints Review
NJR - l-IES/PEDW Linked Dat aset for ASR Hip Resurfacing
Page 5 of 13
DEPUY000291928
SEP 112-2 Rev A
IV. Recommendation
The HHE Committee recommend: No further action is required , complete Corrective and Preventative Action based on review of failure investigation and close file.
(Document Rational)
f ^ I Board level review of this issue and consideration of field action.

The action recommended by the HHE Committee is to recall the distributed product from all markets a nd establish a strategy for
making products available, if necessary, for compassionate use.

(Please Print and Sign your Name)
Complaint Manager Date:
Date:
R..g^.
Product Development Engineer Date:
Operations Manager/ BU Manager (Where applicable)
Date: cm ic1c^ ^ t
Marketing Manager
(Where Applicable)
Date:
Date: Date:
Other
A pp r ov al
The HHE Committee Recommendation is Check App rop riate Box) Director Quality Systems I] Approved El Reject
Date:
Date: ......................................................................
Director Regulatory *
Date:
* Or Nominated Deputy Attachments: Complaints Review NJR - HES/PEDW Linked Dataset for ASR Hip Resurfacing
Page 5 of 13
DEPUY000291929
The action recommended by the HHE .,mm ittee is to retail the distributed product frr
the markets global l y,

(Please Print and Sion your Name) Complaint Manager _. E Date:
bate:
I Product Development Engineer
Date:
Operations Manager/BlJ Manager

(Where applicable)
pate: Date:
Marketing Manager
(Where Applicable)
Date: Date:
Other
Approval
The HHE Committee Recommendation is u Approved u Reject Date:
(Check Appropriate Box)

Director Quality Systems *
WWVP Quality Systems
Date:
Director Regulatory
Date'
* Or Nominated Deputy Attachments: Complaints Review NJR - HES!PEDWWW kinked Dataset for "SR Hic Resurfamnc
Si. i:> i s'--? i-r ?v r'.
azard/Rh.k Ev luati
A The HHE
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DEPUY000291931
l-SHY 112-3 Rely A
HEALTH HAZARD/RISK EVALUATION EXECUTIVE REVIEW BOARD

Complaint No. 12725 - DePu y ASK"' Articular Surface. Rep lacement and ASR1 XL Monoblock Metal-on-Metal (MOM) System
Brief de.crip)fion of event/afw n aa'y:
New information has become available which shows a statistically significant revision rate of 12.0% at 5 years for DePuy ASR
cups with ASR femoral components in a national registry dataset based cohort of 1,599 cases (unpublished NJR - FI S/PI::DW Link e d Dataset for ASR Hip Re sur facing) While the r esu r facing class' revision rate is 6.0 %. F or a s imi la r population, the
reported 3-year revision rate for DePuy ASR cups with ASR femoral components was 6.9% compared to 4.2% for the resurfacing class. While the NJR - HES/PEDW Linked Dataset for the ASR XL system is not yet available, from former data it is not expected
that the 5-year revision rate for ASR cups with ASR XL modular heads will be significantly different compared to the ASR
Resurfacing; one. Because of the potential for a comparably high revision rate, all components within the ASR System are being recalled. Many factors contribute to the overall revision rate for ASR Cups, so a single root cause cannot be defined at this time. Reasons for revision identified within the datascts remain consistent for the class of large diameter metal-on-metal monoblock cups and
include component loosening, component malalignment, infection, fi-acture, dislocation and metal-sensitivity. The effectiveness of actions taken within the last two years that could improve the 5 year revision rate cannot be gauged because the product is
being discontinued. Therefore the 1-111E. Committee believes that the analysis of the collective dataset provides reasons to take field action. The action recommended by the 1-11-I1 Committee is to remove the distributed product from all markets and establish a strategy for making products available, if necessary, for compassionate use.
Market Action Strategy

CLASS A defective product that would affect product performance and/or could cause health
problems
CLASS B defective product or labelling unlikely to cause health problems
CLASSC
market action not involving defective product and/or labelling ,
or
mark et action
re s u lt ing
from causes outside the control of the Company.
Depth of market: User or consumer level Affiliate/distributor level Retail Level
Page I ol'2
DEPUY000291932
F-S&11 112-? itrv .t
IdensiI_vMarket Action rcc;u i Cd

Sec above (411' paragraph) for market action identilied by the 11111, comm ittee..
Recall distributed product from the market

A lt'ac liolt elassilleCd as .i r ecall b y a I I ci aith
Atil.
hurity
Nlarket withdrawal
Rentov'aI or correetiolI of' it (Iistrdbuted prodiiet Ill i ll is not. classified as a recall by a I IcslllII !Authority Field Correction
product without it's physical removal to sonic other Autlturily Repair n}ndiliaa{ ion ad justment re-labelling. destruction or iiispeetiun I inelrl iiiug patient Itaoitiluainl,l itt ;i cation that is M d eli:5sdie! as a recall by it 10Ullh _ r
Director E2e ulaiury Sally Iluulcr
L)ale:
/I
R&D
Date:
1'lichaei Barker V/1' World Widc Quality systems Sarah Dccgitn

V/I' Marketing 'funs Lavorv (Date:
I)u4c:
V/I' Operations
1;d itlackcv ^_.__j _..... 1 c+ uI Director Scott Ryan /
IN Ic:
Complaints :f Vii; i:rnre Paul Arnuff
ammal;(W" r
us[nrgc: r ('nrnp{,tint Qrralite
Authorized (. o nopam y Presiclcin (Mvid Floyd
I)afe:
, Scott; Kilburn. Bandy: Rarrkai'attendees: I loy'd. l)ttvid; I)ecgun . Sarah; l)ovc1'-( sit ; fk:vccli .`;tc:vc:I'lonh;tr . I'itltt: Run Sltaughoessl', Jttltlt:'l iiitiE). Niaricnc: Michael: I3orroff. Mick; Isaac. Graham ; I looter. Sa lty^;'I'iii le.v_ Mindy', L u vcrr.'I ota; {) Krtl,ntuitit- Jews.
2 (W2
DEPUY000291933
F-SIiP 112-3 Rev A
Identify Market Action required:

See above (4"' paragraph) for market action identified by the HHE committee. Recall distributed product from the market
An action classified as a recall by a Health Authority
Market withdrawal
Removal or correction of a distributed product that is not classified as a recall by a D[ea]th Authority
Field Correction
Repair modification adjustment re-labelling, destruction or inspection (including patient monitoring) of a
product without it's physical removal to some other location that is not classified as a recall by a I-Icaith
Authority
Director Regulatory Sally Hunter V/P R&1) Michael Barker V/P World Wide Quality Systems Sarah Deegan V/P Marketing Tom Lavery V/P Operations Ed Macke y Legal Director Scott Ryan Complaints & Vigilance Manager or Customer Complaint Quality Paul Arnott Authorized Company President David Floyd Date: Date: Date: Date: 9/1/10 Date: Date: Date: Date:
Attendees: Floyd, David; Deegan, Sarah; Dover, Carl; Dowell, Steve; Plouhar, Pam; Ryan, Scott; Kilburn, Randy; Barker, Michael; Borroff, Mick; Isaac, Graham; I hunter, Sally; Tinsley, Mindy; Lavery, Tom; O'Shaughnessy, John; Tandy, Marlene; Krugmann, Jens.
Page 2 of '2
DEPUY000291934
F-SEP 112-3 Rev A
Identify Market Action required: See above (4t' paragraph ) for market action identified by the HHE committee.

Market withdrawal
Removal or correction of a distributed product that is not classified as a recall by a Health Authority
Field Correction
Repair modification adjustment re-labelling, destruction or inspection (including patient monitoring) of a product without it's physical removal to some other location that is not classified as a recall by a Health
Authority
Director Regulatory Sally Hunter VIP R& D Michael Barker DateDate:
V/P World Wide Quality Systems Sarah Deegan

VIP Marketing 'T'om Laver y V/P Operations Ed Mackey
Date:
Date:
Date:
Legal Director
Scott Ryan
Date:
Complaints & Vigilance Manager or Customer Complaint Quality Paul Arnott Authorized Company President David Floyd
Date:
Date:
Attendees: Floyd, David; Deegan, Sarah; Dover, Carl; Dowell, Steve; Plouhar, Pam; Ryan, Scott; Kilburn, Randy; Barker, Michael; Borroff, Mick; Isaac, Graham; Hunter, Sally; Tinsley, Mindy; Lavery, Tom; O'Shaughnessy, John; Tandy, Marlene; Krugmann, Jens.
Page 2 of 2
DEPUY000291935
} .g}a' 11 2-1 ftc. A
Ic cnliiv Mail ei Ace on ^'cd>>ired: See abo v e

( 4(11 paragra p h )
for niarlc et
a cti
on
identified
by the 11111e colkuniltec.
Recall tlistr ibutccl product from the marke t

An action c^lassillcd as a recall by a l lcallh Authority
la)111oval fn corre ction ofa dislrihlttcd p roduct that i5 not classilled as a recall by ,i 1 leallh Atithonly
m odi1l1Cla(i Otl ad ]ll5l nlC:[ lt I'C-IahGlllll ];, C]l':St l'tIULIUII or inspection ( 111ClllflllY^ 1)alltinl 111n11ItOrl Slf_} U1 a Rep ai r 111Od
Market wvifhdrawal
Held
product -,1'Itho1lL
physical 1CI1loval to 50100 l)lher loc al lot) that IS not classi lie(t a5 a recall by a I cal lh D;lte:
nulhoniy
1)1rcc(Ut ' l;^l'^T, lllatot'}'
Sal]} iiklnEc )'
.^-
f l; i..
tl
2,
VIE' 1&I)
michaO Barker
Dare: --- --- ----
----------/t' World Wile Quality Systwils Sarah Deegan Mari et Ltt ;::;
Date,
1)11 r:
i tions
1' d 1.taclcey
I,cgal 1) l rCctln' Scull 12yS ll
Date;
Dale;
(:oi l) plaltits Paul At' iott
& V1gllhlncc
"a nage r o r C ilst o tllct
co mp la int
Qu a
l ity
Dal e:
Author i zed Company Presidcut David Floyd
Date
Attendees: Floyd. David; l)ccLan, Sarah; Dover. Call; Dowell, Steve; ]'louhaur, 1'ai11; 1Zvan, Scotl; Kilburn, Randy; 13arkcr, Michael; I3orrofl, Mick; ];Saac. Graham; I lilnier, Sal]) ; 1ins]cy, ivtinllp; I aver, l oat; O'Shaughncs y, John; "I ailcl^, M; t lcnc; l,rllgnllktlll, .fens.
t111'C2ot"2
DEPUY000291936
F-SEP 112-3 Rev A
Identify Market Action required:
See above (4th' paragraph) for market action identified by the HH:F committee. Recall distributed product from the market
Market withdrawal
Field Correction
repair modification adjustment re-labelling, destruction or inspection (including patient monitoring) of a product without it's physical removal to some other location that is not classified as a recall by a Health Authority Date: Director Regulatory Sally Hunter VIP It&D Michael Darker VIP World Wide Quality Systems
Sara IL Deegan ---......._^ V/P Marketing ..........
Date:
Date:
Date:
Tom Lavery V/P Operations Ed Mackey Legal Director Scott Ryan Complaints & Vigilance Manager or Customer Complaint Quality
Date: Date:
Date:
Paul Arnott
Authorized Company President David
Date:
Floyd
Attendees: Floyd, David; Deegan, Sarah; Dover, Carl; Dowell, Steve; Plouhar, Pam; Ryan, Scott; Kilburn, Randy; Barker, Michael; Borroil; Mick; Isaac, Graham; Hunter, Sally; Tinsley, Mindy; Lavery, Tom; O'Shaughnessy, John; Tandy, Marlene; Krugmann, Jens.
DEPUY000291937
1 -SEN t 12-3 Rev A
Identify Markel: Action required:

1i See above (4t p ara g rap h )
for mar ket
act ion ident i fi e d by th e 1111E
committee.

An action classified as a recall by a I-Icalth Authority
Market withdrawal
Field Correction
Repair modification adjustment re-labelling, destruction or inspection (Including patient monitoring) of a
product without it's physical removal to some other location that is not classified as a recall by a Health Authority Date: Director Regulatory
Sally I-1011ter
V/P I2&I)
Michael Barker
Date:
V/P World Wide Quality Systems Saaah Deegan VIP Marketing

't'om Lavery
Date:
Date:
VIP Operations
Ed Mackey
Date:
Legal Director
Scott Ryan
Date:
Co111pEaitlis
Paul AI'noiY
Vigilance, Manager or Customer C: 3pi
Quality
Date: 2CJf o 10 Date:
Authorized Company President , David Floyd
Attendees; Floyd, Davici; Deegan, Sarah; Dover, Car]; Dowell, Steve; Plouhar, Pam; Ryan, Scott; Kilburn, Randy; Barker, Michael; florroff, Mick; Isaac, Graham; I-hinter, Sally; Tinsley, Mindy; Lavery, Torn; O'Shaughnessy, John; Tandy, Marlene; Klugmann , .lens,
t'agc 2 o12
DEPUY000291938
112-3 Rev A
Identify Market Action required: See above (4th paragraph) for market action identified by the HHE committee. Recall distributed product from the market
Market withdrawal
Field Correction
Repair modification adjustment re-labelling, destruction or inspection (including patient monitoring) of a product without it's physical removal to some other location that is not classified as a recall by a Health
Authority Director Regulatory Date:
Sally Hunter
V/P R&D Michael Barke r Date:
Z , -, ^
Date:
V/P World Wide Quality Systems Sarah Deegan
V/P Marketing
Tom Lavery
Date:
V/P Operations
Ed Mackey Legal Director Scott Ryan Complaints & Vigilance Manager or Customer Complaint Quality
Date:
Date:
Date:
Paul Arnott
Authorized Company President David Floyd Date:
Attendees, Floyd, David; Deegan, Sarah; Dover, Carl; Dowell, Steve; Plouhar, Pain; Ryan, Scott; Kilburn, Randy; Barker, Michael; Borroff, Mick; Isaac, Graham; Hunter, Sally; Tinsley, Mindy; Lavery, Tom; O'Shaughnessy, John; Tandy, Marlene; Krugrnann, Jens.
Page 2 of 2
DEPUY000291939
SEP 112-2 Rev A

Attachment:
US codes 510(k) Cleared

Part Number US 510k 510k ASR Acetabular Cups
9998-00-744 9998-00-746 9998-00-748 9998-00-750 9998-00-752 9998-00-754 9998-00-756 9998-00-758 9998-00-760 9998-00-762 999805764 999805966 999806168
Description
ASR ACETABULAR IMPLANT 44 ASR ACETABULAR IMPLANT 46 ASR ACETABULAR IMPLANT 48 ASR ACETABULAR IMPLANT 50 ASR ACETABULAR IMPLANT 52 ASR ACETABULAR IMPLANT 54 ASR ACETABULAR IMPLANT 56 ASR ACETABULAR IMPLANT 58 ASR ACETABULAR IMPLANT 60 ASR ACETABULAR IMPLANT 62 TOTAL ASR ACET IMP SIZE 64 TOTAL ASR ACET IMP SIZE 66 TOTAL ASR ACET IMP SIZE 68
TOTAL ASR ACET IMP SIZE 70 999806370 510k ASR femoral primary heads (aka hemis) ASR FEMORAL IMPLANT SIZE 39 9998-90-039 9998-90-041 9998-90-043 9998-90-045 9998-90-046 9998-90-047 9998-90-049 9998-90-051 9998-90-053 9998-90-055 9998-90-057 9998-90-059 9998-90-061 9998-90-063 510k ASR fem XL modular heads 9998-90-239 9998-90-241 9998-90-243 9998-90-245 9998-90-246 9998-90-247 9998-90-249 9998-90-251 9998-90-253
ASR FEMORAL IMPLANT SIZE 41 ASR FEMORAL IMPLANT SIZE 43 ASR FEMORAL IMPLANT SIZE 45 ASR FEMORAL IMPLANT SIZE 46 ASR FEMORAL IMPLANT SIZE 47 ASR FEMORAL IMPLANT SIZE 49 ASR FEMORAL IMPLANT SIZE 51 ASR FEMORAL IMPLANT SIZE 53 ASR FEMORAL IMPLANT SIZE 55 ASR FEMORAL IMPLANT SIZE 57 ASR FEMORAL IMPLANT SIZE 59 ASR FEMORAL IMPLANT SIZE 61 ASR FEMORAL IMPLANT SIZE 63
ASR U N I FEMORAL IMPL SIZE 39 ASR UNI FEMORAL IMPL SIZE 41 ASR U N I FEMORAL IMPL SIZE 43 ASR U N I FEMORAL IMPL SIZE 45 ASR UNI FEMORAL IMPL SIZE 46 ASR U N I FEMORAL IMPL SIZE 47 ASR UNI FEMORAL IMPL SIZE 49 ASR UNI FEMORAL IMPL SIZE 51 ASR U N I FEMORAL IMPL SIZE 53
Page 6 of 13
DEPUY000291940
SEP 112-2 Rev A

9998-90-255 999890157 999890159 999890161 999890163 Adapter Sleeves 9998-90-340 9998-90-343 9998-90-346 9998-90-349 9998-00-312 9998-00-315 9998-90-333 9998-90-353 9998-00-318
ASR UNI FEMORAL [MPL SIZE 55 ASR UNI FEMORAL IMPL SIZE 57 ASR UNI FEMORAL IMPL SIZE 59 ASR U N I FEMORAL IMPL SIZE 61 ASR UNl FEMORAL IMPL SIZE 63 ASR TAP SLV ADAP 11/13 +0 ASR TAP SLV ADAP 11/13 +3 ASR TAP SLV ADAP 11/13 +6 ASR TAP SLV ADAP 11/13 +9 ASR TAP SLV ADAP 12/14 +2 ASR TAP SLV ADAP 12/14 +5 ASR TAP SLV ADAP 11/13 -3 ASR TAP SLV ADAP 12/14 -1 ASR TAP SLV ADAP 12/14 +8
510k ASR fem XL Anatomic modular heads and tapers ( same Int) ASR XLA SM L Sleeve 11/13 -3 999899025 ASR XLA SM L Sleeve 11/13 +0 999899035 999899045 999899055 999899019 999899029 999899039 999899049 999899059 999899069 ASR XLA SML Sleeve 11/13 +3 ASR XLA SML Sleeve 11/13 +6 ASR XLA SML Sleeve 11/13 +9 ASR XLA STD Sleeve 11/13 -3 ASR XLA STD Sleeve 11/13 +0 ASR XLA STD Sleeve 11/13 +3 ASR XLA STD Sleeve 11/13 +6 ASR XLA STD Sleeve 11/13 +9
510k ASR 300 Cups ( same as Int)
999830744 999830746 999830748 999830750 999830752 999830754 999830756 999830758 999830760 999830762 999830764 999830766
ASR 300 Size 44 ASR 300 Size 46 ASR 300 Size 48 ASR 300 Size 50 ASR 300 Size 52 ASR 300 Size 54 ASR 300 Size 56 ASR 300 Size 58 ASR 300 Size 60 ASR 300 Size 62 ASR 300 Size 64 ASR 300 Size 66
Page 7of13
DEPUY000291941
SEP 112-2 Rev A

999830768 999830770
Additional Codes 999800764 999800766 999800768 999800770 999890257 999890259 999890261 999890263 999800139 999800141 999800143 999800145 999800146 999800147 999800149 999800151 999800153 999800155 ASR ACETABULAR CUPS 64 ASR ACETABULAR CUPS 66 ASR ACETABULAR CUPS 68 ASR ACETABULAR CUPS 70 ASR I)N! FEMORAL IMI'L SIZE 57 ASR UNI FEMORAL IMPL SIZE 59 ASR UNI FEMORAL IMPL SIZE 61 ASR UNI FEMORAL IMPL SIZE 63 ASR UN! FEMORAL IMPL SIZE 39 ASR UNI FEMORAL IMPL SIZE 41 ASR UNI FEMORAL IMPL SIZE 43 ASR UNI FEMORAL IMPL SIZE 45 ASR UNI FEMORAL IMPL SIZE 46 ASR UNI FEMORAL IMPL SIZE 47 ASR UNI FEMORAL IMPL SIZE 49 ASR UNI FEMORAL IMPL SIZE 51 ASR UNI FEMORAL IMPL SIZE 53 ASR UNI FEMORAL IMPL SIZE 55
ASR 300 Size 68 ASR 300 Size 70
US codes
IDE Study (In progress) Part Number US IDE IDE/PMA ASR Acetabular Cups 9998-00-044
9998-00-046 9998-00-048 9998-00-050 9998-00-052 9998-00-054 9998-00-056 9998-00-058 9998-00-060 9998-00-062 9998-00-064 9998-00-066
Description
TOTAL ASR ACET IMP SIZE 44 TOTAL ASR ACET IMP SIZE 46 TOTAL ASR ACET IMP SIZE 48 TOTAL ASR ACET IMP SIZE 50 TOTAL ASR ACET IMP SIZE 52 TOTAL ASR ACET IMP SIZE 54 TOTAL ASR ACET IMP SIZE 56 TOTAL ASR ACET IMP SIZE 58 TOTAL ASR ACET IMP SIZE 60 TOTAL ASR ACET IMP SIZE 62 TOTAL ASR ACET IMP SIZE 64 TOTAL ASR ACET IMP SIZE 66
TOTAL ASR ACET IMP SIZE 68 9998-00-068 TOTAL ASR ACET IMP SIZE 70 9998-00-070 IDE ASR femoral heads - obsolete TOTAL ASR FEM IMP SIZE 39 9998-01-532 TOTAL ASR FEM IMP SIZE 41 9998-01-534
Page 8 of 13
DEPUY000291942
SEP 112-2 Rev A

9998-01-536 9998-01-538 9998-01-539 9998-01-540 9998-01-542 9998-01-544 9998-01-546 9998-01-548 9998-01-550 9998-01-552 9998-01-554 9998-01-556 PMA ASR femoral heads 9998-03-039 9998-03-041 9998-03-043 9998-03-045 9998-03-046 9998-03-047 9998-03-049 9998-03-051 9998-03-053 9998-03-055 9998-03-057 9998-03-059 9998-03-061 9998-03-063 TOTAL ASR FEM IMP SIZE 43 TOTAL ASR FEM IMP SIZE 45 TOTAL ASR FEM IMP SIZE 46 TOTAL ASR FEM IMP SIZE 47 TOTAL ASR FEM IMP SIZE 49 TOTAL ASR FEM IMP SIZE 51 TOTAL ASR FEM IMP SIZE 53 TOTAL ASR FEM IMP SIZE 55 TOTAL ASR FEM IMP SIZE 57 TOTAL ASR FEM IMP SIZE 59 TOTAL ASR FEM IMP SIZE 61 TOTAL ASR FEM IMP SIZE 63
TOTAL ASR FEM IMP SIZE 39 TOTAL ASR FEM IMP SIZE 41 TOTAL ASR FEM IMP SIZE 43 TOTAL ASR FEM IMP SIZE 45 TOTAL ASR FEM IMP SIZE 46 TOTAL ASR FEM IMP SIZE 47 TOTAL ASR FEM IMP SIZE 49 TOTAL ASR FEM IMP SIZE 51 TOTAL ASR FEM IMP SIZE 53 TOTAL ASR FEM IMP SIZE 55 TOTAL ASR FEM IMP SIZE 57 TOTAL ASR FEM IMP SIZE 59 TOTAL ASR FEM IMP SIZE 61 TOTAL ASR FEM IMP SIZE 63
International codes International Part Number Commercial
Description
International ASR Acetabular Cups TOTAL ASR ACET IMP SIZE 44 999803944 TOTAL ASR ACET IMP SIZE 46 999804146 TOTAL ASR ACET IMP SIZE 48 999804348 TOTAL ASR ACET IMP SIZE 50 999804550 TOTAL ASR ACET IMP SIZE 52 999804652 999804754 999804956 999805158 999805360 999805562 999805764 TOTAL ASR ACET IMP SIZE 54 TOTAL ASR ACET IMP SIZE 56 TOTAL ASR ACET IMP SIZE 58 TOTAL ASR ACET IMP SIZE 60 TOTAL ASR ACET IMP SIZE 62 TOTAL ASR ACET IMP SIZE 64
Page 9 of 13
DEPUY000291943
SEP 112-2 Rev A
Health Hazard / Risk Evaluation

999805966 999806168 TOTAL ASR ACET IMP SIZE 70 999806370 International ASR femoral primary heads TOTAL ASR FEM IMP SIZE 39 999803239 TOTAL ASR FEM IMP SIZE 41 999803441
999803643 999803845 999803946 999804047 999804249 999804451 999804653 999804855 999805057 999805359 999805561 999805763
TOTAL ASR ACET IMP SIZE 66 TOTAL ASR ACET IMP SIZE 68
TOTAL ASR FEM IMP SIZE 43 TOTAL ASR FEM IMP SIZE 45 TOTAL ASR FEM IMP SIZE 46 TOTAL ASR FEM IMP SIZE 47 TOTAL ASR FEM IMP SIZE 49 TOTAL ASR FEM IMP SIZE 51 TOTAL ASR FEM IMP SIZE 53 TOTAL ASR FEM IMP SIZE 55 TOTAL ASR FEM IMP SIZE 57 TOTAL ASR FEM IMP SIZE 59 TOTAL ASR FEM IMP SIZE 61 TOTAL ASR FEM IMP SIZE 63
ASR UNI FEMORAL IMPL SIZE 39 ASR UNI FEMORAL IMPL SIZE 41 ASR U NI FEMORAL IMPL SIZE 43 ASR U NI FEMORAL IMPL SIZE 45 ASR U Ni FEMORAL IMPL SIZE 46 ASR UNI FEMORAL IMPL SIZE 47 ASR U NI FEMORAL IMPL SIZE 49 ASR UNI FEMORAL IMPL SIZE 51 ASR UNI FEMORAL IMPL SIZE 53 ASR UNI FEMORAL IMPL SIZE 55 ASR UNI FEMORAL IMPL SIZE 57 ASR U NI FEMORAL IMPL SIZE 59 ASR UNI FEMORAL IMPL SIZE 61 ASR U NI FEMORAL IMPL SIZE 63
International ASR fem modular XL heads 999890139 999890141 999890143 999890145 999890146 999890147 999890149 999890151 999890153 999890155 999890157 999890159 999890161 999890163 999800200 999800203 999800206 999800209 999800102 999800105 999800300 999800303 999800313 999800201 999800207
ASR TAP SLV ADAP 11/13 +0 ASR TAP SLV ADAP 11/13 +3 ASR TAP SLV ADAP 11/13 +6 ASR TAP SLV ADAP 11/13 +9 ASR TAP SLV ADAP 12/14 +2 ASR TAP SLV ADAP 12/14 +5 ASR TAP SLV ADAP 9/10 0 ASR TAP SLV ADAP 9/10 +3 ASR TAP SLV ADAP 9/10 -3 ASR TAP SLV ADAP 11/13-3 ASR TAP SLV ADAP 12/14 -1
Page 10 of 13
DEPUY000291944
SEP 112-2 Rev A

ASR TAP SLV ADAP 12/14 +8 999800108 510k ASR fern XL Anatomic modular heads and tapers (same as US) ASR XLA SML Sleeve 11/13 -3 999899025 999899035 999899045 999899055 999899019 999899029 999899039 999899049 999899059 999899069 999899039 999899041 999899043 999899045 999899046 999899047 999899049 999899051 999899053 999899055 999899057 999899059 999899061 999899063 999899018 999899028 999899038 999899048 999899058 999899014 999899024 999899034 999899044 999899054 ASR XLA SML Sleeve 11/13 +0 ASR XLA SML Sleeve 11/13 +3 ASR XLA SML Sleeve 11/13 +6 ASR XLA SML Sleeve 11/13 +9 ASR XLA STD Sleeve 11/13 -3 ASR XLA STD Sleeve 11/13 +0 ASR XLA STD Sleeve 11/13 +3 ASR XLA STD Sleeve 11/13 +6 ASR XLA STD Sleeve 11/13 +9
ASR XL Anatomic Head Size 39 ASR XL Anatomic Head Size 41 ASR XL Anatomic Head Size 43 ASR XL Anatomic Head Size 45 ASR XL Anatomic Head Size 46 ASR XL Anatomic Head Size 47 ASR XL Anatomic Head Size 49 ASR XL Anatomic Head Size 51 ASR XL Anatomic Head Size 53 ASR XL Anatomic Head Size 55 ASR XL Anatomic Head Size 57 ASR XL Anatomic Head Size 59 ASR XL Anatomic Head Size 61 ASR XL Anatomic Head Size 63
ASR XLA +8 Sleeve 12/14 -3.5 ASR XLA +8 Sleeve 12/14 -1 ASR XLA +8 Sleeve 12/14 +2 ASR XLA +8 Sleeve 12/14 +5 ASR XLA +8 Sleeve 12/14 +8 ASR XLA +4 Sleeve 12/14 -3.5 ASR XLA +4 Sleeve 12/14 -1 ASR XLA +4 Sleeve 12/14 +2 ASR XLA +4 Sleeve 12/14 +5 ASR XLA +4 Sleeve 12/14 +8
510k ASR 300 cups (same as US) 999830744 999830746 999830748
ASR 300 Size 44 ASR 300 Size 46 ASR 300 Size 48

Page 11 of 13
DEPUY000291945
SEP 112-2 Rev A

999830750 999830752 999830754 999830756 999830758 999830760 999830762 999830764 999830766 999830768 999830770 Additional International Codes 999800238 999800240 999800242 999800244 999800245 999800246 999800248 999800250 999800252 999800254 999800256 999800258 999800260 999800262 256688236 256688371 256688402 256688495 256688628 256688799 812899170 812899207 812899226 812899337 812899456 812899532 Additional codes 999800046 999800048 999800050 Modular Femoral Head 38 Modular Femoral Head 40 Modular Femoral Head 42 Modular Femoral Head 44 Modular Femoral Head 45 Modular Femoral Head 46 Modular Femoral Head 48 Modular Femoral Head 50 Modular Femoral Head 52 Modular Femoral Head 54 Modular Femoral Head 56 Modular Femoral Head 58 Modular Femoral Head 60 Modular Femoral Head 62 ASR Total Femoral Implant Size 55 RSA ASR Total Femoral Implant Size 49 RSA ASR Total Femoral Implant Size 57 RSA ASR Total Femoral Implant Size 47 RSA ASR Total Femoral Implant Size 51 RSA ASR Total Femoral Implant Size 53 RSA ASR Total Acetabular Implant RSA Size 54 ASR Total Acetabular Implant RSA Size 54 ASR Total Acetabular Implant RSA Size 54 ASR Total Acetabular Implant RSA Size 54 ASR Total Acetabular Implant RSA Size 54 ASR Total Acetabular Implant RSA Size 54 ASR 300 Size 50 ASR 300 Size 52 ASR 300 Size 54 ASR 300 Size 56 ASR 300 Size 58 ASR 300 Size 60 ASR 300 Size 62 ASR 300 Size 64 ASR 300 Size 66 ASR 300 Size 68 ASR 300 Size 70
ASR ACETABULAR IMPLANT 46 ASR ACETABULAR IMPLANT 48 ASR ACETABULAR IMPLANT 50

Page 12 of 13
DEPUY000291946
SEP 112-2 Rev A

999800052 999800054 999800056 999800058 999800060 999800062 999800064 999800066 999800068 999801534 999801536 999801538 999801540 999801542 999801544 999801546 999801548 999801550 999801552 999801554 ASR ACETABULAR IMPLANT 52 ASR ACETABULAR IMPLANT 54 ASR ACETABULAR IMPLANT 56 ASR ACETABULAR IMPLANT 58 ASR ACETABULAR IMPLANT 60 ASR ACETABULAR IMPLANT 62 ASR ACETABULAR IMPLANT 64 ASR ACETABULAR IMPLANT 66 ASR ACETABULAR IMPLANT 68 TOTAL ASR FEM IMP SIZE 41 TOTAL ASR FEM IMP SIZE 43 TOTAL ASR FEM IMP SIZE 45 TOTAL ASR FEM IMP SIZE 47 TOTAL ASR FEM IMP SIZE 49 TOTAL ASR FEM IMP SIZE 51 TOTAL ASR FEM IMP SIZE 53 TOTAL ASR FEM IMP SIZE 55 TOTAL ASR FEM IMP SIZE 57 TOTAL ASR FEM IMP SIZE 59 TOTAL ASR FEM IMP SIZE 61
Page 13 of 13
DEPUY000291947
ASR - Complaints Review

August 2010
This data is for searches on ASR acetabular products, data considered until 30-June-201 0
ASR Complaints Review -Conclusion
Overall complaint rate: 0 .87% (US: 1.69%; INTL: 0.4%)
loosening , pain, metal reaction remain main complaint types with >70% of all complaints (loosening 1 St in US;' metal reaction 1st in INTL (mainly AUS) Higher failure rates for smaller cup sizes (<52mm; US & overall)
No influence of cup size on implantation time

Similar failure types and implantation time between gender Different failure types between XL and Resurfacing No peak in implantation time Ongoing trend in complaints No change in complaint type pattern over time Further increase in total reported complaints expected
DEPUY000291950
Complaint Types - US
om laint t e Dislocation Fractured Bone nfection ncorrect Leg Length oose
etal reaction
Total 41 2 56 2 272
61
US Complaint Types
300 250 200 150 100 50 0
Oise
ain cratch pin out otal
37
84
Q^^^ t '`òm ^ ^
1 33 589
Complaint Types - INTL

Com p laint t Dislocation
: ractured Bone nfection ncorrect Leg Length IRC nose M etal reaction
oise
Total 2
28
INTL Complaint Types
3 1 23 51 66
14
ain
50 1 7 246
og\
Ii 5^ o . 5^ \t`
icratch
pin out otal
Ile
Complaint Types - US & INTL

Complaint type Dislocation Fractured Bone nfection ncorrect Leg Length IRC Total 43 30 59 3 23 323 127
US & INTL Complaint Types

350
300
250 200 150 100 50
oose
Metal reaction oise pain cratch Spin out
otal
51
0
134
2 40
835
Complaint Rates - US
L mplaint type Dislocation ractured Bone nfection ncorrect Leg Length Dose M etal reaction U5 Com laint Rates 0.117 0.006 0.160 0.006 0.779 0.175
US Complaint Rates
Use
ain cratch
S pin out
0.106
0.241 0.003
0.095
Total
1.687
Complaint Rates - INTL

om laint t e )islocation ractured Bone nfection eg Length lRC
Dose M etal reaction
INTL Complaint Rates % 0.003 0.046 0.005 0.002 0.038

0.084 0.109
INTL Complaint Rates %

0.12 0.1 0.08 0.06 0.04 0.02 0 ado ^z ^^
Oise ain cratch pin out rand Total
0.023 0.082 0.002 0.012 0.405
Compla int Rates - US & INTL

am taint type islocation ractured Bone
nfection
US & INTL Complaint Rates %

0.045 0.031 0.062
US & INTL Complaint Rates %
ncorrect Leg Length .IRC oose Metal reaction Noise ain cratch Spin out
Total
0.003 0.024 0.338 0.133 0.053 0.140 0.002 0.042

G
/ 9!
0.873
DEPUY000291957
Complaints per Geographical Area

Distribution per Country
Infection Invest . LIRC 3% 0% 28% 42% 14% 13% 100%
0%
10% 0% 53% 10% 14% 13%
24% 15% 16%

28%
Total Complaints 300 250 200 150 100 50 0
Loosening / Spin Out Metal reaction 1 AVAL Pain Other Total
17% 100%
100%
AU s GB
US
AU & GB cover >80% of all INTL complaints
DEPUY000291959
Total Complaints/Sold Items & Complaint rate - US

depending on Cup Size
Sold Items
7000 6000 5000 4000 3000 2000 1000
Total Complaints 1 Sold Items - US
Total Complaints
140 120 100 80
60
40 20
0
Size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62
Complaint Rate - US
3.5 3 2.5 2 1.5 0.5 0 Size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62
Total Complaints/Sold Items & Complaint rate - INTL

Sold Items
12000 10000
Total Complaints I Sold Items - INTL

50 45 49
Total Complaints
8000
6000
4000
,ZOO**' 7 23
40 30
20
10 0
2000
0
size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62 Size 64
Complaint Rate - INTL

0.6
0.4 3 0.2 1E-15 -0.2 size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62 Size 64
Complaint Rate & Implantation Time US+INTL

Complaint rate [%]
1.6
Implantation time [yrs]

3
Mean Implantation Time US+INT'L [yeirsl

1.2
-Complaint Rate US+INT'L [%J

2.5
2
0.8
1.5
0.4
0.5
0 size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62 Size 64
DEPUY000291963
Failure Type US+INTL

Comparison Female-Male
Complaint rate [%]
0 . 45-' 0.4 1 0.35

0.3 0.25
..
0.2 0.15 0.1 0.05 0
Female s Male
CP
le
Cup Size US+INTL

Total Complaints
Male Total s Female Total
44
46
48
50
52
54
56
58
60
62
N/A
Mean Cup Size: 55.9 (male) vs. 50. 8 (female)
Time to failure US+INTL

Gender female
male
Mean Implantation Time [years]

1.66 1.52
Mean implantation time [yrs] 2 1.6 1.2 0.8 0.4 0 MALE FEMALE
DEPUY000291967
Failure Type - Cups combined with XL vs. Resurfacing (INTL)

Total Complaints 70 i^^ 60 50 40 30 20 10 0 XL Heads
r.
1,81, Ce op J
s Resurfacing
DEPUY000291969
Complaint Rate/Implantation Time - US

depending on year of index surgery (previously by P. Plouhar)
Implantation Time
Complaint rate
2.0% 1.8% 1.6% 1.4% 1.2% 1.0% 0.8% 0.6% 0.4% 0.2%
36-48 months s 24-36 months 12-24 months 1 6-12 months 0-6 months
0.0%
2006 2007 2008 2009 2010
Complaints considered: entered until 30 June 2010
Complaint Rate/Implantation Time INTL

depending on year of index surgery (Cups w XL+Resurfacing)
Complaint rate
Implantation Time
60-72 months rr 48-60 months

36-48 months s 24-36 months 12-24 months
a 6-12 months > 0-6 months
2004
IYear of Implantation
omplalnts /Sold items
2005
200 19/2348
2006
200 8/7644
2007
200 5/11369
2008
200 3/14378
2009
200 9/14319 1/9767 200

depending on year of index surgery (Cups w XL)
Implantation Time
60-72 months s 48-60 months 36-48 months s 24-36 months 12-24 months s 6-12 months 0-6 months
2004
Year of Implantation omplaints/Sold items
2005
200 /600
2006
2007
2008
200 6/9941
2009
zoo 3/10586200 /8038
200200 4/6369 /3236

depending on year of index surgery (Cups w Resurfacing)
Complaint rate
1.0%
Implantation Time
0.8% 60-72 months 0.6% s 48-60 months 36-48 months s 24-36 months 0.4% 12-24 months s 6-12 months
0.2%
0-6 months
0.0%
2004
Year of Implantation ompiaints/Sold items
2005
200 4/2011
2006
2005 5/4818 0/5358
2007
2008
2009
200 200 /2316
zoa
2/4974
zoo
/4345
PROTECTED DOCUMENT . DOCUMENT SUBJECT TO PROTECTIVE ORDER .
DEPUY000291974
Total Complaints/ Type of Failure - US

depending on Stem Type (search XL head based)
Stem Type - US
242
Total Complaints 300 250 200 150 100 50 -
12
28
24
0
G4 l
Total Complaints 20 ,
Disengaged 15 10 5 s Dislocation Infection s Leg length Loose s metalosis PROSTALAC Solution
,. 1
Corail
S-ROM
Summit
TRI-LOCK
PRODIGY
Noise
Total Complaints/Type of Failure - INTL

depending on Stem Type (search XL head based)
Stem Type - INTL
T175
Total Complaints 120

100 80 60 40 20 0 Corail C-Stem 32
2
Not Given Proxima Silent Hip S-ROM Summit Ultima Vision Solution
Total Complaints 10
ALVAL Dislocation Factured hip s Infection Leg Lenth s Loose
i7l
Corail
C-Stem Proxima Silent Hip S-ROM Summit Ultima Vision Solution
Metalosis 0 Noise Pain
DEPUY000291977
Complaint Types over Time

US & INTL
Total Complaints
500
2010 projected
450 400 350 300 250 200 150 Pain Metal reaction Loose Loose
i
projected 03, Q4 2010
Incorrect Leg Length s Spin out

Scratch Pain Pain Noise
M et al reacFion PainMet it reaction Loose
Meta l reaction
Loose s LIRC Infection s Fractured Bone Dislocation
100
50 0 2004 2005 2006 2007
2008
2009
2010 YTD
10 e'
Complaints, Sold Items over Time

US & INTL
Total Complaints
600 23467 22740
Sold Items
25000
500 16262 16981 II 300 j
k 20000
15000 Sales -Total
400
200
100
2003
2004
2005
2006
2007
2008
2009
2010 YTD
----= projected Complaints
Date of In dex Surgery (DOI), Date of Revision (DOR) over Time

US & INTL
Total Cases DOI I DOR
400
Sold Items
300
200
100
2004
2005
2006
2007
2008
2009
2010
projected DOI
projected DOR
DEPUY000291981
(D
DEPUY000291982
NJR - HES/PEDW Linked Records

The UK NJR was set up in 2003 and data submission is mandatory for Independent Sector hospitals, but voluntary for NHS hospitals in England and Wales It is recognised that due to slow start-up, consenting and the non-mandatory data submission, the NJR is an incomplete dataset with respect to revisions Linking of NJR primaries to routinely collected NHS statistics has therefore been used by the NJR since 2005 to generate a robust cohort for analysis used in the NJR Annual Reports
Datasets
NJR - data entered by hospitals on to the National Joint Registry HES - data reported by the hospitals to national Hospital Episodes Statistics for England
PEDW - data reported by the hospitals to national Patient Episode Data for Wales NJR - HES/PEDW Linked - data that is linked using the patient's national NHS number
NJR 71h Annual Report Extract

NJR - HES/PEDW Linked Dataset from 1St April 2003 to 31St December 2009
ASR Hip resurfacing only 1599 ASR cups with ASR femoral component
- 3 year KM revision rate 6.9% (95%CI 5.7% to 8.5%) - 5 year KM revision rate 12.0% (95%CI 9.3% to 15.4%)
NJR KM calculations on this dataset validated

by DePuy statistician
Summary of Registry Data

3-year KM failure rate 5-year KM failure rate 6.0% 8.7%
5.4%
MA
k '1;4 FyG
3-year KM failure rate
7.5%
4.5%
M OM, INIZI
NJR Report data includes HES-linked revisions and failure rate is thus higher than NJR-only data
COMMERCIAL-IN-CONFIDENCE 5
NJR & HES- Linked Combined Dataset

Dataset : 1St April 2003 to 31St December 2009 1599 records in NJR - HES/PEDW linked cohort
- 1488 unrevised 111 (6.9%) revised
51 revisions on both NJR & HES/PEDW 11 revisions on NJR only 49 revisions on HES/PEDW only
NJR & HES-Linked Combined Dataset

13 additional revisions have occurred in Q1/2 2010 in this cohort of 1599 cases
- 1475 unrevised
- 124 (7.8%) revised
75 cases on NJR (revision reason available) 49 HES-only (no revision reason available)
49 revisions on HES/PEDW only

Reasons for these 49 revisions cannot be determined from NJR records
NJR will collect these retrospectively Validation at two sites last year confirmed reasonable accuracy of HES coding
ASR HR Crude Revision Rate by Year Implanted NJR- HES/PEDW Linked Dataset
16.0%
14.0%
12.0%
10.0%
48-60 months 36-48 months
8.0%
w 24-36 months 12-24 months
6.0%
IN 6-12 months 0-6 months
4.0%
2.0%
0.0% 2003 2004 2005 2006 2007
2008
2009
Implanted Revised % Revised
2003 7 1 14.3%
2004 89 11 12.4%
2005 318 34 10.7%
2006 406 36 8.9%
2007 381 28 7.3%
2008 272 12 4.4%
2009 126 2 1.6%
1599 124 7.8%
Reasons for Revisions

70 60
50
40
30
20
10
0
#NOF
n. Pain Cup Loose Infection Mal Socket Stem loose
^z Both Loose Disloc'n
Ya 3C Ossific'n Cup Wear
r--NR
10
Reasons for Revisions

U Early
70
Late (>90 days)
60
50
40
30
20
10
0 #NOF Pain Cup Loose Infection Mal Socket Stem loose Both Loose Disloc'n Ossific"n Cup Wear NR
11
#NOF
Infection
Pain
Mal'n Cup 9A OnW:
Cup Loose - 0`p1
Stem loose
Both Loose
Disloc'n
Ossific'n
Cup Wear
NR 0,03 0,04
0.04 0.06 0.06
U:)7
EARLY <90 DAYS
0030 0.10 0.15 0.15 0.17 U2
0.0'
0.02
x!03
0.10
0.11.
0.70
10
3.26
1.4
1,61
LATE >90 DAYS
0013 0.40 0.70 aA
2.61
4 03 4;7
12
Reasons for Revision by Year of Index Surgery NJR-HES/PEDW Linked Dataset

40
35
30
NR Cup Wear
25
Cssific'n Disloc'n
20
Both Loose Stem loose Cup Loose
15
Mal'd Cup * Pain
* Infection 10 * #NOF
2003
2004
2005
2006
2007
2008
2009
implanted Revised % Revised
7 1 14.3%
89 11 12.4%
318 34 10.7%
406 36
8.9%
381 28
272 12
126 2
7.3%
4.4%
1.6%
13
U1 O
Nargol Cobb Scott (Chesterfield) Bhamra Drabu Jain Zb Low volume <6 Blom, Eastaugh-Waring Stockley Maheson Smith Tavares George, McWilliams Bamford
Emerton, MacDonald Scott (Aintree) Shoaib
UWAMOMME
RM
no
^- C
rn
CD
wrmmmmm"Ay
V)
Zafiropoulos Pradhan Apthorpe Shetty Hoad-Reddick, Porter Slater, Ravikumar Bagga Jain, Samsani Nunn Shaw DosRemedios Venu, Li Radford Jaramillo Davidson, Kershaw Wimshurst et al West Young
.p
DEPUY000291995
Revisions/100 obs comp yrs

Revisions per 100 observed component years = x 100 number of revisions total observed time (years)]
Surgeon Nunn Shetty Shoaib West Young Bamford Slater, Ravikumar Smith Bagga Cobb Jain, Samsani Zb Low volume <6 Emerton, MacDonald Jain Drabu Scott(Aintree) Scott (Chesterfield) DosRemedios Venu, Li Stock ley Apthorpe Radford Wimshurstetal Nargol Blom, Eastaugh-Waring Davidson, Kershaw Tavares Pradhan Bhamra Maheson Hoad-Reddick, Porter Zafirepoulos Shaw George, McWilliams Jaramillo mplanted 19 22 27 7 5 43 20 61 19 196 19 76 33 77 81 27 89 15 14 66 22 13 11 205 71 11 54 23 83 61 21 24 19 53 12 Revised 0 0 0 0 0 1 1 3 1 10 1 4 2 3 7 1 6 1 1 6 1 1 1 20 7 1 4 2 12 8 3 2 3 8 3 Crude lo ,^ 0.0% 0.0% 0.0% 0.0% 0.0% 2.3% 5.0% 4.9% 5.3% 5.1% 5.3% 5 .3% 6.1% 3.9% 8.6% 3.7% 6.7% 6.7% 7.1% 9.1% 4.5% 7.7% 9.1% 9.8% 9.9% 9.1% 7.4% 8.7% 14.5% 13.1% 14.3% 8.3% 15.8% 15.1% 25.0% Observed Revs1100 Years w, obs comp 62.7 0.0 0.0 57.6 55.2 0.0 16.2 0.0 14.8 0.0 134.4 0.7 1.3 77.6 227.3 1,3 73.1 1.4 715.2 1.4 61.3 1.6 1.6 255.2 1.8 113.3 167.1 1.8 376.5 1.9 53.8 1.9 318.8 1.9 48.4 2.1 47.1 2.1 2.3 265.8 42.0 2.4 2.5 39.3 2.7 36.6 726.2 2.8 228.1 3.1 31.6 3.2 125.5 3.2 60.2 3.3 318.3 3.8 204.1 3.9 74.4 4.0 48.1 4.2 58.5 5.1 151.1 5.3 42.8 7.0
NJR-HES/PEDW HR Class = 1 .37 revs/I 00 obs camp yrs
P.
NJR-HES/PEDW ASR = 2.42 revs1100 obs comp yrs
15
Head Size Distribution

Revisions by Head Size
,: Implanted m Revised
42-43
47-48 49-50
Revisions by Head Size

0 Implanted 100% 80% 460% 40% 20% 0% 36-40 Revised Implanted 5 41 8 29 46
17 47-48 49-50 24
M Revised 0
51 22 304
53 14 245
55 2 10
59 1 13
61 1 3
14 262
169
203
16
Gender and Head Size
Revised
Gender Female Male Ye S 57 57 N 418 984
Risk Ratio =
2.19 Female gender
Revised
Head Size <50mm >50mm Ye 84 40 N of 785 I 635
Risk Ratio =
1.63for head diameters <50mm
17
ASR and ASR XL NJR-NJR Linked Revisions

2009 and 2010 NJR-NJR Datasets Dataset Implanted 13-Jul-10 2800 13-Jul-10 3200 22-Feb-10 22-Feb-10 18-Dec-10 2745 3155 2679 Revised 145 147 121 114 110 Crude Rev Rate% 5.2% 4.6% 4.4% 3.6% 4.1% Dead 24 64 22 61 17 Unrevised 2631 3000 2602 2980 2552 ASR HR ASR XL ASR HR ASR XL ASR HR
ASR XL
ASR HR ASR XL
18-Dec-10
20-Aug-09 20-Aug-09
3095
2561 2881
98
89 66
3.2%
3.5% 2.3%
39
14 32
2958
2458 2783
18
ASR and ASR XL NJR-NJR Datasets

KM Survival KM Failure Std error 95%LCI 95%UCI
20 August 2009 ASR HR 5 years ASR XL 5 years 93.08% 93.34% 6.92% 6.66% 0.0123 0.0159 90.67% 90.22% 95.49% 96.46%
18 December 2009 ASR HR 5 years ASR XL 5 years 92.93% 92.99% 7.07% 7.01% 0.0091 0.0119 91.2% 90.7% 94.7% 95.3%
13 July 2010 ASR HR 5 years

ASR XL 5 years
91.76%
91.44%
8.24%
8.56%
0.0078
0.0103
90.24%
89.42%
93.28%
93.46%
ASR HR and ASR XL have similar failure rates based on non-HES data ASR XL overtook ASR HR in latest dataset by a small margin
19

ASR Articular Surface Replacement Risk Evaluation

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SEP 112-2 Rev A

Health Hazard/Risk Evaluation

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0-3 4-6 7-9 10-12 I

Hazard/Risk Index If Index is > 7, Field Action has to be considered

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Health Hazard/Risk Evaluation IV Recommendation

based on review of failure investigation and close file.

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Quality Systems Manager

Product Development Engineer

Operations ManagerfBU Manager

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Health Hazard/Risk Evaluation W :Recomm endation

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The HHE Committee Recommendation is

(Check Appropriate Box Director Quality Systems *

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