DePUY ASR HIP IMPLANT RECALL – WHAT DID DePUY KNOW, AND WHEN?

FOR FURTHER INFORMATION AND RELATED BLOG ENTRIES VISIT OUR DEDICATED DePUY HIP IMPLANT RECALL PAGE

In the period between July of 2003 and the announcement by DePuy Orthopaedics, Inc. on the 26th of August last of a worldwide recall of its ASR XL Acetabular System and ASR Hip Resurfacing System, 93,000 of these devices were distributed worldwide, with over 3,500 Irish patients having received one or other of these implants.

The obvious question that raises itself is: “what did DePuy learn on the 26th August 2010 that it had not previously known to prompt it to announce the recall?”  If you consider the developments leading up to the recall, you’d have to say “not much.”

In the annual report of the Australian Orthopaedic Association’s National Joint Replacement Registry (NJRR) published in August of 2007, it was noted that the data collated in Australia for the year ending the 31st December 2006 showed that the resurfacing parts of these devices had at least twice the risk of revision compared to other resurfacing devices.

But this finding clearly showed itself to be no statistical blip – in the NJJR’s 2008 annual report the ASR cup was “re-identified in this report as having a higher than anticipated rate of revision when used in total resurfacing procedures.”  The report went on to note that while the ASR continued to be used in Australia as of the end of 2007, the number of implants was declining due to the fact that this prosthesis had more than twice the risk of revision compared to other total resurfacing prostheses.

In the NJJR’s 2009 annual report it was noted that “the ASR has been identified in its own right and not in combination with other femoral stems.  When used in total resurfacing hip replacement the ASR has also been identified as having a higher than anticipated risk of revision.

The 2009 report’s executive summary went on to state that “it is not uncommon for orthopaedic manufacturers to attribute these differences to surgeon learning curve.”  In other words, DePuy’s response to the suggestion that it was manufacturing defective devices was to retort that the real problem was that the medical professionals performing the procedures were the cause of the rot because they had not yet got their heads round how to implant these wonderful devices correctly.  Interestingly, though, the executive summary went on to observe:  “This approach however does not explain why most new prostheses are not identified as having a higher than anticipated rate of revision.

Notwithstanding DePuy’s protestations that bad tradesmen were blaming the tools of their trade, the company nevertheless voluntarily withdrew the ASR from the Australian market in December 2009.

In an interview conducted in February of this year, DePuy officials defended the ASR’s track record, saying its performance equalled that of competing devices.  The officials went on to say that the decision to phase out sales of the device which was announced at that time was for purely commercial reasons, not because of any safety issues.

In its press release announcing the recall in August DePuy stated that its decision was prompted by “new data”, specifically the findings contained in the 2010 annual report of the National Joint Registry for England and Wales.  The press release went on to state that, according to other international joint replacement registries, ASR implants were performing in line with other devices of a similar kind.

This prompted the director of the NJJR, Professor Stephen Graves, to make the following statement in a radio interview which he gave on Australia’s ABC Radio National on the 30th August 2010, four days after the announcement:

“Yes, I’ve noticed that comment in the press release and I couldn’t quite understand that because that’s simply not correct because DePuy were fully aware of the Australian registry data. So I’m not quite sure why they’ve said that because it’s simply not true.”

We have been contacted by Irish patients who received an ASR implant since the voluntary recall in Australia last December.  DePuy’s disingenuous stance will be particularly galling for these individuals, especially if revision surgery is deemed necessary.

As may be seen in our related blog on the DePuy ASR hip implant recall, the figures which have been circulated by DePuy regarding the complications associated with these prostheses should be regarded with severe wariness, with information from other sources suggesting that the volume of chrome and cobalt ions which is typically absorbed by the bloodstream and organs of an ASR implant patient is disconcertingly high, being about an average of ten times that of conventional metal-on-plastic systems.

If you have been affected by the ASR hip implant recall and would like to arrange a free initial consultation with John McCarthy feel free to call him on 023 883 3348023 883 3348 or email him at john@mccarthy.ie to discuss your case in complete confidence and without commitment.

FOR FURTHER INFORMATION AND RELATED BLOG ENTRIES VISIT OUR DEDICATED DePUY HIP IMPLANT RECALL PAGE

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John specialises in personal injury and medical negligence claims. His practice focuses on high value compensation cases. He has extensive experience in this area of litigation for over 10 years. Read more