FDA Posts ASR Recall Info Months After Global Voluntary DePuy Recall
Almost 8 months ago DePuy Orthopaedics, Inc. issued a worldwide recall of its ASR hip implant system. So why did the FDA wait until last week to quietly post ASR recall notices on its website for dozens of the DePuy ASR Hip implants?
On March 24, 2011, the FDA website listed 68 recall records for various versions of the DePuy ASR hip implants. Back on July 17, 2010, the FDA also issued a recall notice for the DePuy ASR 100 Acetabular implant. Below is the reason given by the FDA for the July 2010 recall:
“Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports…
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorship [sic].”
In the fall of 2009 and in March of 2010 DePuy publicly said they were discontinuing sales of the ASR hip system. If that was really the case, then why would DePuy need to “reiterate the importance of correct implant positioning…” in their July 2010 recall notice? Once they stopped selling the ASR and pulled it from the market, no surgeons should have been implanting this hip replacement anyway.
In the July Recall, DePuy also states that they are “continually evaluating data from a variety of sources including national joint replacement registries.” If DePuy was actually monitoring this information as they say, they must have known about the high rate of ASR failures as indicated by the Australian Registry back in 2007. Yet they continued to sell and aggressively market the product in the United States until 2010. That’s 3 years worth of “evaluating data” before they finally decided to recall the ASR.
So why is the FDA only NOW posting this detailed recall information 8 months after the high profile worldwide recall by DePuy?
We have several emails out to the FDA public affairs office to find out more. We’ll let you know what they say and find out if there is any further reason for concern for the almost 100,000 people with a recalled DePuy ASR hip implant.
Contact the DePuy ASR Hip Recall Law Firm Alliance for more information about how you should proceed with a claim if you have one of these bad hips.
