HHE Coordinator: Jens Krugmann Product Data

Health Hazard/Risk Evaluation

HHE Coordinator:Jens Krugmann

Product DataProduct Name : DePuy ASR" Articular Surface Replacement (Not approved for use in the US) and ASRT"' XMetal-on-Metal System

Product Codes Affected

See attached

LotNumberslSerial

Numbers(As known)

All

Manufacturer:(If external include Name and Contact Information)DePuy International, Ltd.St. Anthony's RoadLeedsLS 11 8DT

Page 1 of 13

FinishedGoods

SEP 112-2 Rev A

Monoblock

Quantity(As known)

Distributor Sold

Approx.98,000systems

PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY000291920

Health Hazard/Risk EvaluationSEP 112-2 Rev A

Complaint, Incident, Problem Reported:

Attachments:

1, Complaints Review2. NJR - HESIPEDW Linked Dataset for ASR Hip Resurfacing

Following our previous HHE conducted on 8th January 2010 our ongoing Post Market Surveillance Activities have identifiedadditional 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 ArticularSurface Replacement and ASR® XL Monoblock Metal-on-Metal (MUM) System linked to usage of monoblock MoM cups withcorresponding 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(joint replacement registries,published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports). TheAustralian National Joint Replacement Registry had reported a cumulative percentage revision rate of 5.4% at 3 years for theASR® Cup and XL head used with DePuy stems in total hip replacement. At that time recent published and unpublished datasuggested that this rate may be higher in cohorts where a large proportion is female or has small acetabulae. These datasuggested that smaller heads (less than 50 mm diameter) are associated with a higher rate of revision (up to 8-9 % at threeyears). While the analysis conducted at that time did not demonstrate conclusive findings regarding the relationship betweengender and implant head size, DePuy believed that the analysis of the collective dataset provided reasons to take special carein patient selection and cup placement when choosing to use the DePuy ASR TM Articular Surface Replacement and ASR® XLMonoblock Metal-on-Metal System with head sizes below 50 mm, (cup sizes 56 mm and smaller). This data was consistent withother published data for the use of the DePuy ASR monoblock metal-on-metal resurfacing system and other similar devices inthe class.Following the former HHE, actions recommended by the HHE Committee were taken to provide a Dear Doctor letter to previousand current users of the ASR platform to inform them of our recent analysis of datasets from various sources and remind themon several aspects in order to achieve optimal implant performance and survivorship (please see HEALTH HAZARD/RISKEVALUATION 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 femoralcomponents (NJR - HES/PEDW Linked Dataset for ASR Hip Resurfacing) while the class' revision rate is 6.0%. For a similarpopulation 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 significantlylower.

Number of Complaints , Incidents , Problems Reported:

See attached complaints review and NJR - HES/PEDW Linked Dataset for ASR Hip ResurfacingNumber of Injuries : As above Number of Deaths: 0Source of Reports:Hospital Patient qePU /J&J Affiliate

qX q or Distributor X

Complaint No.: Ref. HHE DINT 12725

Page 2 of 13


Health Hazard/Risk EvaluationSEP 112-2 RevA

ll. Problem Definition and AnalysisProduct 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 performancemetal-on-metal bearings designed and manufactured within fine tolerances to facilitate a state of fluid film lubrication. Thesystem 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 aclass to have a more challenging implantation technique than conventional total hip replacement. Reasons for revisionidentified within the datasets are typical for the class of large diameter MoM monoblock cups and includes componentloosening, 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 devicesthroughout the class. No evidence that a specific population group is at greater risk attributed to the application of ASR whencompared 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 reverseimpairment. Successful revision surgery will obviate any long range consequences.

aint No.: RefHHE dated 15 September, 2008

Page 3 of 13


Health Hazard/Risk Evaluation

Remote

Rare

Occasional

Frequent

Continuously Occurring

Ill.HealthlRisk IndexLikelihood of Occurrence

Probability ofExtremely Unlikely

Unlikely but Possible

Likely

Very Likely

Extremely Likely

Circles the appra-0

+1

+2

of the Product Issuelate value

SEP 112-2 Rev A

Comments:The product issue is defined as early revision of theprosthesis due to loosening or adverse tissue reaction.The available data suggests an increase in revision rates forASR cups with ASR femoral components at 5 years.Reference attached NJR - HES/PEDW Linked Dataset forASR Hip Resurfacing.Although the revision rate has increased the HHECommittee considers a "frequent" rate marked as "3" as stillappropriate.

the Product Issue resulting in Health Hazard t0

+1

+2

+4

Severity of the HealNone (No adverse Health Consequences)

Limited (Transient , Self-limiting Illness or injury

Moderate (Significant Impairment, buttemporary/reve rsible)

Sever (Serious Injury , Permanent Impairment,Irreversible)

Life Threat ( Life threatening , Death Could Occur)

0

+1

C+9+3

+4

Comments:The probability of the product issue (defined as earlyrevision of the prosthesis due to loosening or adverse tissuereaction) resulting in a health hazard or risk is considered"very likely".

h HazardlRiskComments:The immediate consequence of cup loosening or adversetissue reaction is the necessity for revision surgery toreverse impairment. Successful revision surgery isexpected to obviate any long range consequences. As withall revision surgery there are associated risks, in isolatedcases permanent impairment could occur related to adversereactions to metal debris.

Hazard/Risk Index(Obtained by adding the scores of the above three sections

ilnctlcate score in lineRZarO/N{SK lrm eX l3OX}NonefNegligible/Broadly Acceptable

Low/As Low As Reasonably Practicable (ALARP)

Moderate/Undesirable

High/Unacceptable

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

0-3 Comments:Revision rates are higher than the class and higher thanthose for conventional total hip replacement surgeries4-6where the PinnacleTM cup is used.Although the revision rate has increased the HHE7-9Committee considers a "HazardJRisk index" of "8" as stillappropriate.10-12However, additional actions were determined asnecessary.II

8

Complaint No.: Ref. HHE dated 15 September, 2008

Page 4 of 13


112-2 Rev A

Health Hazard/Risk EvaluationIV Recommendation

The HHE Committee recommend:

No further action is required , complete Corrective and Preventative Actionbased on review of failure investigation and close file.

(Document Rational)

qX 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 formaking 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 Date:(Where applicable)

Marketing Manager(Where Applicable)C ^^.

Date:

Medical Professional Date:(Required for Health Risk Evaluation not submitted to the board)

Other Date:

Approval....The HHE Committee Recommendation is 11 v/ Approved El Reject

(Check_Appropriate Box]

Director Quality Systems * Date:

WW VP Quality Systems * Date:

Director Regulatory * Date:

Or Nominated Deputy

Attachments:Complaints ReviewNJR - HES/PEDW Linked Dataset for ASR Hip Resurfacing

Page 5 of 13


Health Hazard/Risk EvaluationW :Recomm endation


I

SE P 1 12-2 Rev A


(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 CommitteeE'Eease Print ancf Sign your Namc

Complaint Manager

Quality Systems Manager

Product Development Engineer

Operations Manager113UJ Manager(Where applicable)

Marketing Manager(Whore Applicable)

Medical Professional(Required for Health Risk Evaluation not submitted to the board)

Other

The HHE Committee Recommendation is(Check Appropriate Box)

Director Quality Systems *

WW VP Quality Systems

Director Regu latory ^,-iOr Nominated Deputy

Attaciarnents:Comp€aints ReviewNJR - I-IES/PEDW I_inkoci Datasot for ASR Hip Resurfacing

Pape 5 of 13

Approval

Date:

Date:

Date:

Date:

Date:

1::1 3 Approved I[.] Reject

-----____.- ......_.........Dato:

Date:

1 Date:


Health Hazard/Risk EvaluationIV. Recom mendation

SEP 112-2 Rev A

L--1 No further action is required, complete Corrective and Preventative Actionbased on review of failure investigation and close file.

(Document Rational)

x 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 formaking products availab#e, if necessary, for compassionate use.

Health Hazard/Rick Evaluation CommitteePlease Pt'itlt and,Sign your Name

Complaint Manager

Quality Systems Manager

Operations Manager/BU Manager

(Where applicable)

Marketing Manager(Whore Applicable)

Medical Professional(Required for Health Risk Evaluation not submitted to the board)

Other

The HHE Committee Recommendation is(Check Appropriat(j l3ox)__..__ -.--Director Quality Systems

WW VP Quality Systems

Director Regulatory

* Or Nominated Deputy

Attachments:Complaints ReviewNJR - I-{ES/PEDW Linked Dataset for ASR I-tip Resurfacing

Pago 5 01 13

C Date_^^.

Date:

Date:

1

PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER . DEPUY000291926

Health Hazard/Risk Ev U Ce i9 a nSEP'112-2 RevA

W. • Recommendation


El No further action is required , complete Corrective and Preventative Actionbased on review of failure investigation and close tile-

(Docurnent Rational)

}C Board level review of this issue and consideration of field action.(Attachment C is required)

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

Health Hazard/Risk Evaluation CommitteePlease Print and Sigour Name)

Complaint Manager Late:


Product Development F_ngineer Date:

Operations ManagerfBU Manager Date:(Where Applicable)

Marketing Manager Late(Whore Applicable)

Medical Professionalb d

D ate ôar )(fie aired f r I ealth Risk Evaluation not submitted to the

`. "• Xi r to__

Other.

Date:

The HHE Committee Recommendation is 3 Approved Reject

(Check Appropriate Box



Director Regulatory Date:


Attachments:Complaints ReviewN,JR - HES/I'EDW Linked Dataset for ASP Hip Resurfacing

Page 3of13


Health Hazard/Risk EvaluationIV. Recommendation


SEP 112-2 Rev A

(^ No further action is required, complete Corrective and Preventative Actiontt ^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 formaking products available, if necessary , for compassionate use.

Health Hazard/Risk Evaluation Committee(Please Print and;5r.n yqul NameComplaint Manager f

Quality Systerns Manager

Product Development Enghi er

(_ 11^-\ .\. 111\ \t

Operations Manager/BU Manager(Where applicable)

Marketing Manager(Where Applicable)

Medical Professional(Required for Health Risk Evaluation not subrnitted to the board)

I

Other

The t-IHE Committee Recommendation is-.(Check Appropriate Box)

Director Quality Systems

WW VP Quality Systems * -

1 Director Regulatory

Or Nominated Deputy

-Approval['.IV Approved

AttachmontS:Complaints ReviewNJR - l-IES/PEDW Linked Dataset for ASR Hip Resurfacing

Page 5 of 13

CI Reject

Date:

Date:

Date;

Date:

Date:

Date:

Date:

Date:

Date:

Date: -


Health Hazard/Risk EvaluationSEP 112-2 Rev A

IV. Recommendation



(Document Rational)

f ^ I 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 formaking products available, if necessary, for compassionate use.

Health Hazard/Risk Evaluation Committee(Please Print and Sign your Name)Complaint Manager Date:


R..g^. 2

Product Development Engineer Date:

Operations Manager/BU Manager(Where applicable)

Date:

^cm ic1c^ t

Marketing Manager Date:(Where Applicable)


Other Date:

.App roval

The HHE Committee Recommendation is I] 3 Approved El RejectCheck App ropriate Box)

Director Quality Systems Date:


......................................................................Director Regulatory * Date:


Attachments:Complaints ReviewNJR - HES/PEDW Linked Dataset for ASR Hip Resurfacing

Page 5 of 13


The action recommended by the HHE .,mm ittee is to retail the distributed product frr the markets global l y,

Health Hazard/Risk Evaluation Committee(Please Print and Sion your Name) _.Complaint Manager E Date:

Quality Systems Manager bate:

I Product Development Engineer Date:

Operations Manager/BlJ Manager pate:(Where applicable)

Marketing Manager Date:(Where Applicable)


Other Date:

ApprovalThe HHE Committee Recommendation is q3 Approved q Reject(Check Appropriate Box)


WWVP Quality Systems Date:

Director Regulatory Date'


Attachments:Complaints ReviewNJR - HES!PEDWWW kinked Dataset for "SR Hic Resurfamnc

The HHEA Co,,;;n oiti ee reco mend:

azard/Rh.k Ev luatiSi. i:> i s'--? i-r ?v r'•.

Nofwi

actiond

-xl.^f arot R•

^,î.^r{Rî^^RaVGa^^

cxsc tt,êG ^` es

â^^{^nâ sâg e^s'Âa''.,^^,^% ^&,s^

r.'rl^ ^^V^ and k-•^',^^,v ^.£ôanv

UfF? nt Marnag 9r

5.-...(-'4 ^f t1 Ll lei . kJLii^kt)€JIJSL_ fL k^Fî$^k 3^^^3

car, ea ons FVl FI Gt-/E U fV`sina er

j -7

3 W. t.clwui Gt"s w c

i'i i.F }.':11 f 1 IK , 111; ;(',

";,L HI AE Committee 1 eco r, en io iC1Che -[c Appropriate Box'

L)ne i o to it's ^'r::.; ka

i._ ............._...-_...-.._.._..... __.._....__.....,...........k


l-SHY 112-3 Rely A

HEALTH HAZARD/RISK EVALUATIONEXECUTIVE REVIEW BOARD

Complaint No. 12725 - DePuy ASK"' Articular Surface. Rep lacement and ASR1 XL Monoblock Metal-on-Metal (MOM) System

Brief de.crip)fion of event/afw naa'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

Linked Dataset for ASR Hip Resurfacing) While the resurfacing class' revision rate is 6.0 %. For a s imi lar population, the

reported 3-year revision rate for DePuy ASR cups with ASR femoral components was 6.9% compared to 4.2% for theresurfacing class.

While the NJR - HES/PEDW Linked Dataset for the ASR XL system is not yet available, from former data it is not expectedthat the 5-year revision rate for ASR cups with ASR XL modular heads will be significantly different compared to the ASRResurfacing; one. Because of the potential for a comparably high revision rate, all components within the ASR System are beingrecalled.

Many factors contribute to the overall revision rate for ASR Cups, so a single root cause cannot be defined at this time. Reasonsfor revision identified within the datascts remain consistent for the class of large diameter metal-on-metal monoblock cups andinclude component loosening, component malalignment, infection, fi-acture, dislocation and metal-sensitivity. The effectivenessof actions taken within the last two years that could improve the 5 year revision rate cannot be gauged because the product isbeing discontinued. Therefore the 1-111E. Committee believes that the analysis of the collective dataset provides reasons to takefield action.

The action recommended by the 1-11-I1 Committee is to remove the distributed product from all markets and establish a strategyfor 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

U CLASSC market action not involving defective product and/or labelling , or market action res 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


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 marketA lt'ac liolt elassilleCd as .i recall by a I I ciaith Atil.hurity

Nlarket withdrawalRentov'aI or correetiolI of' it (Iistrdbuted prodiiet Ill i ll is not. classified as a recall by a I IcslllII !Authority

Field CorrectionRepair n}ndiliaa{ ion ad justment re-labelling. destruction or iiispeetiun I inelrl iiiug patient Itaoitiluainl,l itt ;i

product without it's physical removal to sonic other cation that is M d eli:5sdie! as a recall by it € 10Ullh

Autlturily _

Director E2e ulaiury L)ale:

Sally Iluulcr

/I R&D

1'lichaei Barker

V/1' World Widc Quality systems

Sarah Dccgitn

V/I' Marketing

'funs Lavorv

V/I' Operations

1•;d itlackcv

1 c+ uI Director^_.__j _.....

Scott Ryan /°

Complaints :f Vii;€ i:rnre ammal;(W" r us[nrgc: r ('nrnp{,tint Qrralite

Paul Arnuff

Authorized (.o nopam y Presiclcin

(Mvid Floyd

Date:

(Date:

I)u4c:

IN Ic:

I)afe:

attendees: I loy'd. l)ttvid; I)ecgun . Sarah; l)ovc1'-( sit ; fk:vccli .`;tc:vc:I'lonh;tr . I'itltt: Run , Scott; Kilburn. Bandy: R•arrkai'-

Michael: I3orroff. Mick; Isaac. Graham ; I looter. Sa lty^;'I'iii le.v_ Mindy', L q vcrr.'I ota; {) Sltaughoessl', Jttltlt:'l iiitiE). Niaricnc:

Krtl,ntuitit- Jews.

2 (W2

r


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 marketAn action classified as a recall by a Health Authority

Market withdrawalRemoval or correction of a distributed product that is not classified as a recall by a D[ea]th Authority

Field CorrectionRepair modification adjustment re-labelling, destruction or inspection (including patient monitoring) of aproduct without it's physical removal to some other location that is not classified as a recall by a I-Icaith

AuthorityDirector Regulatory Date:

Sally Hunter

V/P R&1) Date:

Michael Barker

V/P World Wide Quality Systems Date:

Sarah Deegan

V/P Marketing Date:

Tom Lavery

V/P Operations Date: 9/1/10

Ed Mackey

Legal Director Date:

Scott Ryan

Complaints & Vigilance Manager or Customer Complaint Quality Date:

Paul Arnott

Authorized Company President Date:

David Floyd

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


F-SEP 112-3 Rev A


See above (4t' paragraph ) for market action identified by the HHE committee.


Market withdrawalRemoval or correction of a distributed product that is not classified as a recall by a Health Authority

Field CorrectionRepair modification adjustment re-labelling, destruction or inspection (including patient monitoring) of aproduct without it's physical removal to some other location that is not classified as a recall by a HealthAuthority


Sally Hunter

VIP R&D Date-

Michael Barker


Sarah Deegan

VIP Marketing

'T'om Laver

Date:

y

V/P Operations Date:

Ed Mackey


Scott Ryan


Paul Arnott


David Floyd

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


} .g}•a' 11 2-1 ftc.• A

Ic cnliiv Mail ei Ace on ^'cd>>ired:

See above (4(11paragra p h ) for niarlcet acti o n identified by the 11111e colkuniltec.

Recall tlistributccl product from the marke tAn action c^lassillcd as a recall by a l lcallh Authority

Market wvifhdrawalla)111oval fn correction ofa dislrihlttcd product that i5 not classilled as a recall by ,i 1 leallh Atithonly

HeldRep ai r 111Od

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

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

nulhoniy

1)1rcc(Ut ' l;^l'^T, lllatot'}'D;lte:

Sal]} iiklnEc )' .^- f l; i.. t l 2,

VIE' 1&I) Dare:

michaO Barker-----------

/t' World Wile Quality Systwils--- --- ----

Date,

Sarah Deegan

Mari et Ltt 1)11 r:

;::;i tions Date;

1' d 1.taclcey

I,cgal 1) l rCctln' Dale;

Scull 12yS ll

(:oi l) plaltits & V1gllhlncc "a nage r o r C ilst o tllct • co mp la int Q u a l ity Dale:

Paul At' iott

Author i zed Company Presidcut Date

David Floyd

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]) ; •1•ins]cy, ivtinllp; I aver, l oat; O'Shaughncs y, John; "I ailcl^, M; t lcnc;

l,rllgnllktlll, .fens.

t111'C2ot"2


F-SEP 112-3 Rev A


See above (4th' paragraph) for market action identified by the HH:F committee.



Field Correctionrepair modification adjustment re-labelling, destruction or inspection (including patient monitoring) of aproduct without it's physical removal to some other location that is not classified as a recall by a HealthAuthority


Sally Hunter

VIP It&D Date:

Michael Darker

VIP World Wide Quality Systems Date:

Sara IL Deegan---......._^ ..........

V/P Marketing Date:

Tom Lavery


Ed Mackey


Scott Ryan


Paul Arnott


David 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.


1 -SEN t 12-3 Rev A

Identify Markel: Action required:

See above (4t 1i paragraph) for market action ident ified by th e 1111E committee.

Recall distributed product from the marketAn action classified as a recall by a I-Icalth Authority


Field CorrectionRepair 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 HealthAuthority


Sally I-1011ter

V/P I2&I) Date:

Michael Barker


Saa•ah Deegan

VIP Marketing Date:

't'om Lavery

VIP Operations Date:

Ed Mackey


Scott Ryan

Co111pEaitlis Vigilance, Manager or Customer C: 3pi Quality Date:

Paul AI'noiY10

2CJf o

Authorized Company President , Date:

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


112-3 Rev A


See above (4th paragraph) for market action identified by the HHE committee.



Field CorrectionRepair modification adjustment re-labelling, destruction or inspection (including patient monitoring) of aproduct without it's physical removal to some other location that is not classified as a recall by a HealthAuthority


Sally Hunter

V/P R&D

rZ

Date:

Michael Barke , -, ^V/P World Wide Quality Systems Date:

Sarah Deegan

V/P Marketing Date:

Tom Lavery


Ed Mackey


Scott Ryan


Paul Arnott


David Floyd

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


Health Hazard/Risk EvaluationAttachment:

US codes

510(k ) ClearedPart Number US 510k

510k ASR Acetabular Cups9998-00-744

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

999806370

510k ASR femoral

9998-90-039

9998-90-041

9998-90-043

9998-90-045

9998-90-046

9998-90-047

9998-90-0499998-90-051

9998-90-053

9998-90-055

9998-90-057

9998-90-059

9998-90-061

9998-90-063

Description

ASR ACETABULAR IMPLANT 44










TOTAL ASR ACET IMP SIZE 64




primary heads (aka

ASR

ASR

ASR

ASR

ASR

ASR

ASR

ASR

ASR

ASR

ASR

ASR

ASR

ASR

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

hemis)FEMORAL IMPLANT SIZE 39

FEMORAL IMPLANT SIZE 41













ASR U N I FEMORAL IMPL SIZE 39

ASR UNI FEMORAL IMPL SIZE 41







ASR U N I FEMORAL IMPL SIZE 53Page 6 of 13

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

Health Hazard/Risk EvaluationASR UNI FEMORAL [MPL SIZE 55




ASR UNl FEMORAL IMPL SIZE 63

ASR TAP SLV ADAP 11/13 +0






ASR TAP SLV ADAP 11/13 -3



510k ASR fem XL Anatomic modular heads and tapers ( same Int)

999899025

999899035

999899045

999899055

999899019

999899029

999899039

999899049

999899059

999899069

510k ASR 300 Cups ( same as

Int)

999830744

999830746

999830748

999830750

999830752

999830754

999830756

999830758

999830760

999830762

999830764

999830766

ASR XLA SM L Sleeve 11/13 -3

ASR XLA SM L Sleeve 11/13 +0

ASR XLA SML Sleeve 11/13 +3



ASR XLA STD Sleeve 11/13 -3

ASR XLA STD Sleeve 11/13 +0




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

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

US codesIDE Study (In progress)

Part Number US IDEIDE/PMA ASR Acetabular Cups9998-00-0449998-00-046

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

9998-00-068

9998-00-070

Health Hazard/Risk EvaluationASR 300 Size 68

ASR 300 Size 70

ASR ACETABULAR CUPS 64




ASR I)N! FEMORAL IMI'L SIZE 57




ASR UN! FEMORAL IMPL SIZE 39










Description















IDE ASR femoral heads - obsolete

9998-01-532 TOTAL ASR FEM IMP SIZE 39

9998-01-534 TOTAL ASR FEM IMP SIZE 41

Page 8 of 13

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

9998-01-556PMA 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

9998-03-0599998-03-061

9998-03-063

International codesInternationalPart NumberCommercial

Health Hazard/Risk EvaluationTOTAL ASR FEM IMP SIZE 43

TOTAL ASR FEM IMP SIZE 45

























DescriptionInternational ASR Acetabular Cups

999803944

999804146

999804348

999804550

999804652

999804754

999804956

999805158

999805360

999805562

999805764












Page 9 of 13

SEP 112-2 Rev A


Health Hazard /Risk Evaluation999805966 TOTAL ASR ACET IMP SIZE 66

999806168 TOTAL ASR ACET IMP SIZE 68

999806370 TOTAL ASR ACET IMP SIZE 70

International ASR femoral primary heads

999803239

999803441

999803643

999803845

999803946

999804047

999804249

999804451

999804653

999804855

999805057

999805359

999805561

999805763















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 U NI FEMORAL IMPL SIZE 43


ASR U Ni FEMORAL IMPL SIZE 46
















ASR TAP SLV ADAP 9/10 0



ASR TAP SLV ADAP 11/13-3


Page 10 of 13

SEP 112-2 Rev A


999800108

Health Hazard/Risk EvaluationASR TAP SLV ADAP 12/14 +8

510k ASR fern XL Anatomic modular heads and tapers (same as US)

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

510k ASR 300 cups (same asUS)

999830744

999830746

999830748

ASR XLA SML Sleeve 11/13 -3





ASR XLA STD Sleeve 11/13 -3





ASR XL Anatomic Head Size 39














ASR XLA +8 Sleeve 12/14 -3.5

ASR XLA +8 Sleeve 12/14 -1

ASR XLA +8 Sleeve 12/14 +2



ASR XLA +4 Sleeve 12/14 -3.5

ASR XLA +4 Sleeve 12/14 -1




ASR 300 Size 44

ASR 300 Size 46

ASR 300 Size 48

Page 11 of 13

SEP 112-2 Rev A


Health Hazard/Risk Evaluation999830750 ASR 300 Size 50

999830752 ASR 300 Size 52

999830754 ASR 300 Size 54

999830756 ASR 300 Size 56

999830758 ASR 300 Size 58

999830760 ASR 300 Size 60

999830762 ASR 300 Size 62

999830764 ASR 300 Size 64

999830766 ASR 300 Size 66

999830768 ASR 300 Size 68

999830770 ASR 300 Size 70

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














ASR Total Femoral Implant Size 55 RSA






ASR Total Acetabular Implant RSA Size 54









Page 12 of 13

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

Health Hazard/Risk EvaluationASR ACETABULAR IMPLANT 52




















Page 13 of 13

SEP 112-2 Rev A


ASR - Complaints Review

August 2010

This data is for searches on ASRacetabular 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


Complaint Types - US

om laint t e Total

Dislocation 41

Fractured Bone 2

nfection 56

ncorrect Leg Length 2

oose 272

etal reaction 61

Oise 37

ain 84

cratch 1

pin out 33

otal 589

300

250

200

150

100

50

0

US Complaint Types

Q^^^ t '`òm ^° ^

Complaint Types - INTL

Com p laint t e Total

D islocation 2

: ractured Bone 28

nfection 3


IRC 23

nose 51

Metal reaction 66

oise 14

ain 50

icratch 1

pin out 7

otal 246

INTL Complaint Types

og\ Ii 5^ o . 5^ \t`

Ile

Complaint Types - US & INTL

Complaint type Total

Dislocation 43

Fractured Bone 30

nfection 59


IRC 23

oose 323

Metal reaction 127

oise 51

pain 134

cratch 2

Spin out 40

otal 835

US & INTL Complaint Types

350

300

250

200

150

100

50

0

Complaint Rates - US

Lmp laint type U5 Com laint Rates

D islocation 0.117

ractured Bone 0.006

nfection 0.160

ncorrect Leg Length 0.006

Dose 0.779

Metal reaction 0.175

Use 0.106

ain 0.241

cratch 0.003

Spin out 0.095

Total 1.687

US Complaint Rates

Complaint Rates - INTL

om laint t e INTL Complaint Rates %

)islocation 0.003

ractured Bone 0.046

nfection 0.005

eg Length 0.002

lRC 0.038

Dose 0.084


Oise 0.023

ain 0.082

cratch 0.002

pin out 0.012

rand Total 0.405

y

INTL Complaint Rates %0.12

0.1

0.08

0.06

0.04

0.02

0

°^âdo ^z

Complaint Rates - US & INTL

am taint typeUS & INTL Complaint

Rates %

islocation 0.045

ractured Bone 0.031

nfection 0.062

ncorrect Leg Length 0.003

.IRC 0.024

oose 0.338


Noise 0.053

ain 0.140

cratch 0.002

Spin out 0.042

Total 0.873

US & INTL Complaint Rates %

I

/9!

G°


Complaints per Geographical AreaDistribution per Country

Total Complaints

300

250

200

150

100

50

0

AU & GB cover >80% of all INTL complaints

Infection 3% 0% 10%

Invest . LIRC 0% 24% 0%

Loosening / Spin Out 28% 15% 53%

Metal reaction 1 AVAL 42% 16% 10%

Pain 14% 28% 14%

Other 13% 17% 13%

Total 100% 100% 100%

AU

s GB

US


Total Complaints/Sold Items &Complaint rate - USdepending on Cup Size

Sold ItemsTotal Complaints 1 Sold Items - US

Total Complaints140

120

100

80

7000

6000

5000

4000

3000

2000

1000

0

Size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62

3.53

2.52

1.5

0.50

Complaint Rate - US

Size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62

60

40

20

0

Total Complaints/Sold Items &Complaint rate - INTLdepending on Cup Size

Sold Items

12000

10000

8000

6000

4000

2000

0

Total Complaints I Sold Items - INTL

50 45 49

Total Complaints

,ZOO**'23

7

size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62 Size 64

Complaint Rate - INTL0.6

0.4 3

0.2

1E-15

-0.2size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62 Size 64

40

30

20

10

0

Complaint Rate & Implantation TimeUS+INTLdepending on Cup Size

Complaint rate [%] Implantation time [yrs]

1.6Mean Implantation Time US+INT'L [yeirsl -Complaint Rate US+INT'L [%J

1.2

0.8

0.4

size 44 Size 46 Size 48 Size 50 Size 52 Size 54 Size 56 Size 58 Size 60 Size 62 Size 64

3

2.5

2

1.5

0.5

0


Failure Type US+INTLComparison Female-Male

Complaint rate [%]

0 45-'.

0.4 1 ..

0.350.3

0.25

0.20.15

0.1

0.05

0

CP le

Female

n Male

Cup Size US+INTLComparison Female-Male

Total Complaints

44 46 48 50 52 54 56 58 60 62 N/A

Mean Cup Size: 55.9 (male) vs. 50. 8 (female)

Male Total

n Female Total

Time to failure US+INTLComparison Female-Male

GenderMean Implantation

Time [years ]

female 1.66

male 1.52

Mean implantation time [yrs]

2

1.6

1.2

0.8

0.4

0

MALE FEMALE

C


Failure Type - Cups combined with XLvs. Resurfacing (INTL)

Total Complaints

70 i^^

60

50

40

30

20

r.XL Heads

10

0

1,81, Ce op J

n Resurfacing


Complaint Rate/Implantation Time - USdepending on year of index surgery (previously by P. Plouhar)

Complaint rate

2.0%

1.8%

1.6%

1.4%

1.2%

1.0%

0.8%

0.6%

0.4%

0.2%

0.0%2006

Implantation Time

2007 2008 2009 2010

36-48 months

n 24-36 months

12-24 months

1 6-12 months

0-6 months

Complaints considered: entered until 30 June 2010

Complaint Rate/Implantation Time -INTLdepending on year of index surgery (Cups w XL+Resurfacing)

8/7644


Complaint rate

2004 2005

Implantation Time

2006 2007 2008 2009

60-72 months

rr 48-60 months

36-48 months

n 24-36 months

12-24 months

a 6-12 months

> 0-6 months

IYear of Implantation 200 200 200 200 200 200omplalnts /Sold items 19/2348 5/11369 3/14378 9/14319 1/9767

Complaint Rate/Implantation TimeINTLdepending on year of index surgery (Cups w XL)

2004 2005

Implantation Time

2006 2007 2008 2009

60-72 months

n 48-60 months

36-48 months

n 24-36 months

12-24 months

n 6-12 months

0-6 months

200 200200 200Year of Implantationomplaints/Sold items /600 /3236 4/6369 6/9941 3/10586200

zoo

/8038


Complaint Rate/Implantation Time -INTLdepending on year of index surgery (Cups w Resurfacing)

Complaint rate

1.0%

0.8%

0.6%

0.4%

0.2%

0.0%

2004 2005

Implantation Time

60-72 months

n 48-60 months

36-48 months

n 24-36 months

12-24 months

n 6-12 months

0-6 months

2006 2007 2008 2009

200 2005 zoa zoo 200 200Year of Implantation/4345 /2316ompiaints/Sold items 4/2011 5/4818 0/5358 2/4974


PROTECTED DOCUMENT . DOCUMENT SUBJECT TO PROTECTIVE ORDER . DEPUY000291974

Total Complaints/ Type of Failure - USdepending on Stem Type (search XL head based)

Total Complaints

30025020015010050 - 12

0

l4G

Total Complaints

20 ,

15

10

5

242

Stem Type - US

28 24

,. 1

Corail PROSTALAC Solution

a y

S-ROM Summit TRI-LOCK PRODIGY

Disengaged

n Dislocation

Infection

n Leg length

Loose

n metalosis

Noise

Total Complaints/Type of Failure - INTLdepending on Stem Type (search XL head based)

Total Complaints

120

100

80

60

40 - 32

20

0

Stem Type - INTLT175

2

Corail C-Stem Not Given Proxima Silent Hip S-ROM Summit Ultima VisionSolution

Total Complaints

10

i7lCorail C-Stem Proxima Silent Hip S-ROM Summit Ultima Vision

Solution

ALVAL

Dislocation

Factured hip

n Infection

Leg Lenth

n Loose

Metalosis

0 Noise

Pain


Complaint Types over TimeUS & INTL

Total Complaints

5002010 projected

450© projected 03, Q4 2010

400 Incorrect Leg Length

350 n Spin out

Scratch300

Pain250 Pain Noise

200 Pain- Meta l reaction-reacMetal FionLoose

150 Pain iMet t reactionn LIRC

Metal reaction Loose100 Infection

LooseLoose n Fractured Bone50

Dislocation0 i

2004 2005 2006 2007 2008 2009 2010 YTD

10 e'

Complaints, Sold Items over TimeUS & INTL

Total Complaints

600

500

400

300

200

100

23467 22740

16262

2003 2004 2005 2006 2007 2008 2009 2010YTD

----= projected Complaints

Sold Items

25000

k 2000016981 j

I I 15000

Sales

-Total

Date of Index Surgery (DOI),Date of Revision (DOR) over TimeUS & INTL

Total Cases DOI I DOR

400

300

200

100

Sold Items

2004 2005 2006 2007 2008 2009 2010

projected DOI projected DOR


z

(D


NJR - HES/PEDW Linked Records

• The UK NJR was set up in 2003 and data submissionis mandatory for Independent Sector hospitals, butvoluntary for NHS hospitals in England and Wales

• It is recognised that due to slow start-up, consentingand the non-mandatory data submission, the NJR isan incomplete dataset with respect to revisions

• Linking of NJR primaries to routinely collected NHSstatistics has therefore been used by the NJR since2005 to generate a robust cohort for analysis used inthe NJR Annual Reports

Datasets

• NJR - data entered by hospitals on to theNational Joint Registry

• HES - data reported by the hospitals tonational Hospital Episodes Statistics forEngland

• PEDW - data reported by the hospitals tonational Patient Episode Data for Wales

• NJR - HES/PEDW Linked - data that is linkedusing the patient's national NHS number

NJR 71h Annual Report Extract

• NJR - HES/PEDW Linked Dataset from 1St April2003 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 validatedby DePuy statistician

Summary of Registry Data

3-year KM failure rate


6.0% 5.4%

8.7%

MA '1;4 FyGk


MOM, INIZI

7.5% 4.5% NJR Report dataincludes HES-linkedrevisions and failurerate is thus higherthan NJR-only data

COMMERCIAL-IN-CONFIDENCE5

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 Q1/22010 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 bedetermined from NJR records

• NJR will collect these retrospectively

• Validation at two sites last year confirmedreasonable accuracy of HES coding

ASR HR Crude Revision Rate by Year ImplantedNJR-HES/PEDW Linked Dataset

16.0%

14.0%

12.0%

10.0%

8.0%

6.0%

4.0%

2.0%

0.0%

48-60 months

36-48 months

w 24-36 months

12-24 months

IN 6-12 months

0-6 months

2003 2004 2005 2006 2007 2008 2009

2003 2004 2005 2006 2007 2008 2009Implanted 7 89 318 406 381 272 126 1599Revised 1 11 34 36 28 12 2 124% Revised 14.3% 12.4% 10.7% 8.9% 7.3% 4.4% 1.6% 7.8%

9

Reasons for Revisions70

60

50

40

30

20

10

0 rn. ^z Y a 3 C r---

#NOF Pain Cup Loose Infection Mal Socket Stem loose Both Loose Disloc'n Ossific'n Cup Wear NR

10

Reasons for RevisionsU Early Late (>90 days)

70

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

EARLY <90DAYS

LATE >90DAYS

#NOF

U:)7

00300.100.150.150.17

U2

Infection Pain Mal'n Cup Cup Loose9A - 0`p1OnW:

0.7010

00130.400.70aA

Stem loose Both Loose Disloc'n

3.26 1.4

Ossific'n

1,61

Cup Wear NR0,030,040.040.060.060.0'0.02x!030.100.11.

2.61

4 03

4;7

12

40

35

30

25

20

15

10

2003

implanted 7Revised 1% Revised 14.3%

2004

Reasons for Revision by Year of Index SurgeryNJR-HES/PEDW Linked Dataset

2005

89 31811 34

12.4% 10.7%

2006

406

368.9%

2007

381

28

7.3%

272

12

4.4%

2008

126

21.6%

2009

NR

Cup Wear

Cssific'n

Disloc'n

Both Loose

Stem loose

Cup Loose

Mal'd Cup

* Pain

* Infection

* #NOF

13

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

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

RM

U1O

A

UWAMOMME

no

W

wrmmmmm"Ay

z CD

^- CV)

rn


Revisions/100 obs comp yrs

SurgeonNunnShettyShoaibWestYoungBamfordSlater, RavikumarSmithBaggaCobbJain, SamsaniZb Low volume <6Emerton, MacDonaldJainDrabuScott(Aintree)Scott (Chesterfield)DosRemediosVenu, LiStock leyApthorpeRadfordWimshurstetalNargolBlom, Eastaugh-WaringDavidson, KershawTavaresPradhanBhamraMahesonHoad-Reddick, PorterZafirepoulosShawGeorge, McWilliamsJaramillo

Revisions per 100 observed component years = number of revisions x 100total observed time (years)]

Observed Revs1100mplanted Revised Crude °lo ,^ Years w, obs comp

19 0 0.0% 62.7 0.022 0 0.0% 57.6 0.027 0 0.0% 55.2 0.0

7 0 0.0% 16.2 0.05 0 0.0% 14.8 0.0

43 1 2.3% 134.4 0.720 1 5.0% 77.6 1.361 3 4.9% 227.3 1,319 1 5.3% 73.1 1.4

196 10 5.1% 715.2 1.419 1 5.3% 61.3 1.6

76 4 5 .3% 255.2 1.633 2 6.1% 113.3 1.877 3 3.9% 167.1 1.881 7 8.6% 376.5 1.927 1 3.7% 53.8 1.989 6 6.7% 318.8 1.915 1 6.7% 48.4 2.114 1 7.1% 47.1 2.166 6 9.1% 265.8 2.322 1 4.5% 42.0 2.413 1 7.7% 39.3 2.511 1 9.1% 36.6 2.7

205 20 9.8% 726.2 2.871 7 9.9% 228.1 3.111 1 9.1% 31.6 3.254 4 7.4% 125.5 3.223 2 8.7% 60.2 3.383 12 14.5% 318.3 3.861 8 13.1% 204.1 3.921 3 14.3% 74.4 4.024 2 8.3% 48.1 4.219 3 15.8% 58.5 5.153 8 15.1% 151.1 5.312 3 25.0% 42.8 7.0

NJR-HES/PEDWHR Class = 1 .37 revs/I 00 obs camp yrs

P. NJR-HES/PEDWASR = 2.42 revs1100 obs comp yrs

15

Head Size DistributionRevisions by Head Size

,: Implanted m Revised

42-43 47-48 49-50

Revisions by Head Size0 Implanted M Revised

100%

80% 4

0

-

60%

40%

20%

0%36-40 41 46 47-48 49-50 51 53 55 59 61

Revised 8 17 24 14 22 14 2 1 1

Implanted 5 29 169 203 262 304 245 10 13 316

Gender and Head Size

Revised Ye

GenderFemale Male

57SN

57418

Risk Ratio = 2.19 Female gender

Revised

Head Size<50mm >50mm

Ye 84N

984

40

of 785 I 635

Risk Ratio = 1.63for head diameters <50mm

17

ASR and ASR XLNJR-NJR Linked Revisions

2009 and 2010 NJR-NJR Datasets

Dataset Implanted Revised Crude Rev Rate% Dead UnrevisedASR HR 13-Jul-10 2800 145 5.2% 24 2631ASR XL 13-Jul-10 3200 147 4.6% 64 3000

ASR HR 22-Feb-10 2745 121 4.4% 22 2602ASR XL 22-Feb-10 3155 114 3.6% 61 2980

ASR HR 18-Dec-10 2679 110 4.1% 17 2552ASR XL 18-Dec-10 3095 98 3.2% 39 2958

ASR HR 20-Aug-09 2561 89 3.5% 14 2458ASR XL 20-Aug-09 2881 66 2.3% 32 2783

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ASR and ASR XL

NJR-NJR Datasets

KM Survival KM Failure Std error 95%LCI 95%UCI

20 August 2009

ASR HR 5 years 93.08% 6.92% 0.0123 90.67% 95.49%

ASR XL 5 years 93.34% 6.66% 0.0159 90.22% 96.46%

18 December 2009

ASR HR 5 years 92.93% 7.07% 0.0091 91.2% 94.7%

ASR XL 5 years 92.99% 7.01% 0.0119 90.7% 95.3%

13 July 2010

ASR HR 5 years 91.76% 8.24% 0.0078 90.24% 93.28%

ASR XL 5 years 91.44% 8.56% 0.0103 89.42% 93.46%

ASR HR and ASR XL have similar failure rates based on non-HES dataASR XL overtook ASR HR in latest dataset by a small margin

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Documents

HHE Coordinator: Jens Krugmann Product Data