Ortho SuperSite, citing a press release issued by DePuy, wrote that the medical device maker also announced it received 510(k) clearance for its RECLAIM Revision Femoral Hip System, a cementless hip revision surgery. Orthopaedic and Spine explained that GRIPTION titanium foam implants will be used in the GRIPTION acetabular augmentation system for hip replacement and GRIPTION cones for knee replacement surgeries.

510(k) approval is a so-called "fast-tracked" approval process used when a manufacturer claims its emerging product is substantially similar to a product or products already approved and on the market. Such fast-tracked approvals enable a device maker to forego the human clinical trial process mandated when seeking to bring a new medical device to market.

This summer, DePuy hip implant devices—the ASR Hip Resurfacing System and the ASR XL Acetabular System—were recalled following numerous complaints from patients and doctors over pain, discomfort, flexibility issues, and ambulation problems. The devices were experiencing higher-than-normal failure rates that have forced patients to undergo removal of the defective implant and reimplantation with a different device in revision surgery procedures.

A design flaw in the metal hip cup is causing some of the problems and physicians have noted that the metal-on-metal implants disburse shards that have left patients with masses in body tissue and increased blood cobalt levels, a potentially dangerous side effect.

If you have been implanted with one of these defective devices, you should immediately seek advice from a lawyer that is knowledgeable about the DePuy hip implant recall and the injuries associated with these hip implants. For a free consultation with such an attorney, complete the form to the right or call 212-566-1000.  Based in New York City, Sullivan & Brill, LLP represents clients throughout the United States.