APPENDIX 5

APPENDIX 5

ASR timelines

Department of Health and Ageing

Answer to Question on Notice

Early 2004

TGA approves ASR Resurfacing

Early 2005

TGA approves ASR XL

Oct 2006

2006 National Joint Replacement Registry (NJRR) annual report released:
Mentions ASR Resurfacing but the difference in revision rates is noted in the report as not significant

June 2007

Orthopaedic Expert Working Group (OEWG) established to review NJRR data

Aug 2007

OEWG meets for the first time –
ASR NOT discussed because it had not been identified as an implant of concern at that stage

Sept 2007

J&J discuss ASR Resurfacing revision rates with TGA
J&J agreed to restrict supply to surgeons who undergo further training, and to issue a Safety Notice to all implanting surgeons advising them of the revision rates and J&J intention to supply only to specially trained surgeons

Oct 2007

2007 NJRR annual report released
Identifies ASR Resurfacing as an implant that is experiencing higher than expected revision rates

Oct 2007

TGA notifies other regulatory agencies
TGA notifies other regulatory agencies of J&J's intended actions regarding ASR Resurfacing in the Australian market through a process called National Competent Authority Reporting (NCAR)

May 2008

J&J provides status report
J&J provides update on status of actions agreed in Sept 2007. Safety Notice sent – as a result of supply being conditional on re-training, 15 surgeons had abandoned the implant, another 16 said that they would continue to use it. Overall use dropped dramatically

May 2008

TGA refers ASR Resurfacing issue to OEWG at its May meeting
ASR Resurfacing, including J&J/TGA actions taken in Sept 2007 referred to OEWG for comment and/or endorsement. OEWG endorses actions taken and recommends that monitoring of the implant continue

June 2008

OEWG meets once again
No change to position regarding ASR Resurfacing

Sept 2008

Internal review of TGA process begins
Following concerns over procedural fairness afforded by the TGA process being used to investigate implants identified as having higher than expected revision rates by the NJRR, TGA initiates an internal review of that process

Oct 2008

2008 NJRR annual report released
Re-identifies ASR Resurfacing as having high revision rates. Identifies that the ASR XL acetabular cup has higher than expected revision rates ONLY when used in conjunction with the Corail femoral stem component

July 2009

Internal review of TGA process ends
The review found that the process is fair and appropriate and was resumed – Implants that were identified for the first time in the 2008 NJRR annual report were processed in 2009

Aug 2009

Out of Session Briefing provided to OEWG
The briefing provided the OEWG a status on the process of consideration of implants identified as having high revision rates in the NJRR reports – with a view to restarting the process

Oct 2009

2009 NJRR annual report released
Re-identifies ASR Resurfacing as having high revision rates. Identifies that the ASR XL acetabular has higher than expected revision regardless of which femoral stem component is used

Oct 2009

TGA and J&J have further discussions about ASR
TGA indicated that in light of the information in the 2009 NJRR report, J&J would be expected to justify on-going supply of the implant. J&J indicated that ASR sales had reduced dramatically, and that there was on-going concern about the implant. This was making the implant unviable so J&J would be withdrawing the implant from the Australian Market however requests that some components be allowed to remain for partial revision purposes

Dec 2009

OEWG meeting includes discussion on ASR XL implant
OEWG endorses the actions taken by J&J and the TGA also endorses the request to allow some components to remain available

Dec 2009

ASR Resurfacing and ASR XL removed from the market

Feb 2010

6th Meeting of OEWG
ASR issue had already been dealt with – no discussion on ASR

June 2010

7th Meeting of OEWG
Discussion about Metal on Metal (MoM) hip implants like the ASR. OEWG advised that there should not be a blanket condemnation of MoM implants – also advised against routine analysis of blood samples for Cobalt and Chromium levels as an indicator of early implant failure

Aug 2010

Worldwide recall of ASR implants

Oct 2010

2009 NJRR annual report released
Re-identifies ASR Resurfacing and ASR XL as having high revision rates

Nov 2010

8th Meeting of OEWG
Action on ASR complete – the committee considered other implants

Mar 2011

9th Meeting of OEWG
Action on ASR complete – the committee considered other implants

May 2011

10th Meeting of OEWG
Further discussions on concerns regarding MoM implants. OEWG re-affirmed the recommendations provided at its 7th meeting in June 2010

June 2011

11th Meeting of OEWG
Action on ASR complete – the committee considered other implants

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