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DePuy Hip Implant

RECALLED HIP REPLACEMENTS MANUFACTURED BY DEPUY ORTHOPAEDICS/JOHNSON & JOHNSON


On December 8, 2011 the FDA issued a Warning Letter in which it informed the public that DePuy, a subsidiary of Johnson & Johnson, was manufacturing 14 different artificial joint components that had not been approved by the FDA. These included knee systems and hip systems. DePuy claimed that these products were exempt from the FDA approval process because they were “substantially equivalent” to preexisting devices and were “custom devices” requested by surgeons to match the anatomy of individual patients. The FDA disagreed because the 14 device components contained “standardized design characteristics,” meaning they were not custom made.


The FDA warning letter also stated that DePuy’s quality system did not comply with all of the FDA’s requirements.


This is not the first time DePuy has come under scrutiny for these devices.  On August 26, 2010, DePuy/Johnson & Johnson issued a recall of their ASR hip implants, including the XL Acetabular System (available worldwide) and the Hip Resurfacing System (approved for use only outside the United States).  These implants are made from cobalt and chromium, and during normal wear and tear, metal would rub against metal and release these toxic metals into the body.


A typical implant is supposed to last for 15 years or longer, but it has been estimated that at least 1 out of every 8 patients who received one of these hip implants has needed corrective surgery within 5 years of the implant.  The rate of defective implants may be even higher, and there have been over 93,000 of these implants worldwide.


The first lawsuit over one of these defective implants was filed in March of 2009, and over the last few years the FDA received between 400 and 500 complaints of early failure, but DePuy/Johnson & Johnson delayed in issuing a recall until August 2010.


DePuy/Johnson & Johnson are now offering compensation in the form of covering medical expenses–nowhere near what an injured patient deserves.  Physicians are being told to refer their patients to DePuy’s claims settlement company, Broadspire.  Please know that these “settlements” do not cover all potential damages, and especially do not cover future injuries that might arise.  You may be unknowingly signing your rights away by agreeing to settle for past medical expenses only.


Contact Heaviside Reed Zaic for a free case evaluation if you received a DePuy Orthopaedics hip implant and experienced complications.


 

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