FDA Seeks More Information on DePuy Pinnacle Hip Replacement

Washington, DCThe US Food and Drug Administration recently ordered all manufacturers of metal-on-metal hip replacement implants such as the DePuy Pinnacle to conduct studies to determine their risks, according to The New York Times.

span itemprop="image" itemscope itemtype="https://schema.org/ImageObject" style="display:block">The news source reports that the studies will examine patients who have received the implants and will look for evidence of metallic debris shedding and other potential side effects that many people have experienced.

Dr. William H. Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health, told the news source that the order reflects the agency's ability to study medical devices after they have been approved for sale.

The federal agency reportedly issued a letter to 20 manufacturers asking for the additional testing, the news provider said.

Johnson & Johnson's DePuy Pinnacle metal-on-metal hip implant has been under scrutiny after the FDA reportedly received hundreds of reports of side effects and adverse events associated with the devices. The DePuy Orthopaedics unit also recalled a significant number of products related to high failure rates in August 2010.