Personal Injury Blog

FDA Finds Continued Complaints about Defective Hip Replacement Devices

August 27th, 2011
Hip replacement device surgery

Defective devices can cause painful and very dangerous symptoms.

Even as California pharmaceutical liability attorneys continue to investigate complaints about defective hip implants, the Food and Drug Administration has announced that it has received a spike in complaints about defective hip replacement devices.

The New York Times analyzed complaints involving hip implant devices, including the ASR devices by DePuy and the Zimmer Durom cup, filed with the Food and Drug Administration from 2007 through June 2011.  The analysis found 7,500 complaints related to the defective DePuy devices.  There were about 6,000 complaints filed about the Durom cup.

The analysis doesn’t reveal exactly how many complaints about defective hip replacement devices have been filed with the Food and Drug Administration.  The complaints are not filed in a standard fashion, which makes it difficult to calculate the exact numbers.  For instance, the New York Times analysis found about 200 complaints about an all-metal version of the Pinnacle device manufactured by DePuy.  The analysis also found at least 400 complaints about metal poisoning injuries suffered by patients who were injured through the Pinnacle device, but the data contains no information on which Pinnacle device these complaints are related to.

The Food and Drug Administration has asked manufacturers of hip implant devices to conduct studies into the safety hazards associated with their use.  Zimmer, DePuy and other companies have already submitted their study proposals to the Food and Drug Administration.  Another company manufacturing implants, Biomet says that it is considering a study of 400 patients, who had been implanted with hip implant devices.

Since January, the Food and Drug Administration has received more than 5,000 complaints about metal-on-metal implants.  That is more than the number of complaints that the agency had received about these implants over the past four years combined.  Most of the complaints filed with the Food and Drug Administration involve patients who had to have the metal-on-metal implants removed, or are scheduled for a procedure to remove their implant soon because of failure.  The implant devices are expected to last for at least fifteen years, if not more.  The study will be too late for those patients who have already been implanted with these defective devices.

One of the biggest recalls associated with defective hip implants has been the one involving implants manufactured by Johnson & Johnson subsidiary DePuy Orthopedics Inc.  In 2010, the company announced a recall of two of its implant devices, including the ASR Hip Resurfacing System and ASR XL Acetabular System.  Some of the patients implanted with these devices can expect a painful and complicated procedure to remove the defective hip replacement devices, while others have already suffered serious injuries from metal ions that have leaked from the devices and into the bloodstream.

 

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