fbpx

Two Other DePuy Products Under Fire By the FDA

Apparently, the apple doesn’t fall far from the tree when it comes to products within the DePuy Orthopaedics family.  The company issued a recall for it’s ASR™ XL Acetabular System and the ASR™ Hip Resurfacing System on August 24th after increased pressure from the FDA.  Reports from the National Joint Registry of England and Wales showed that the products displayed an unacceptable high failure rate.  In fact, within just five years time they claim that one in every eight recipients of the ASR system will require revisional surgery.

As a hip recall lawyer, I’m always skeptical about these statistics put forth by the manufacturing company.  In reality, it may end up being more like one in every three or four people experience a hip implant failure, but time will only tell.  Now other DePuy products are under fire by the FDA, though no official recall has been announced as of yet.  On August 18th, about a week before the ASR™ recall was issued, the Food and Drug Administration issued this letter to the president of DePuy Orthopaedics.  In the letter, the FDA demanded that DePuy immediately cease marketing and distributing a knee replacement and hip replacement product.

Apparently, DePuy put the TruMatch™ knee replacement device on the market without receiving proper approval or clearance from the FDA.  The Corail® hip replacement system was under target by the FDA because DePuy made the claim that it was to be used without cement, though marketing brochures claim otherwise.  As an ASR hip replacement lawyer, I’m skeptical of any product made by DePuy or even Johnson and Johnson at this point.  It’s obvious that these are corporate giants concerned more with profits than their patients well being.