Mar. 5, 2011: Lawyers Developing Protocal to Preserve Recalled J&J Hip Implants

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

We recently wrote that representatives of Johnson & Johnson's DePuy Orthopeadics unit have allegedly been attending revision surgeries to remove defective hip implants from surgical rooms. Some believe the implications of removing medical devices from surgical rooms points to an attempt to prevent evidence from being used in legal proceedings. Now, the pharmaceutical giant and lawyers suing J&J over recalled hip implants are working on a process to preserve and handle devices removed from patients' bodies.

Meanwhile, DePuy Orthopaedics, Inc. just announced that it received two 510(k) clearances from the U.S. Food and Drug Administration (FDA). This type of approval is described as a fast tracking of the traditional approval process used when a manufacturer claims its emerging product is substantially similar to a product or products already approved and on the market. Of note, the clearance enables a device maker to forego the human clinical trial process mandated when seeking to bring a new medical device to market.

The 501(k) approvals were granted for DePuy's GRIPTION® TF, a titanium foam to be used in the GRIPTION acetabular augmentation system (hip replacement) and GRIPTION cones (knee replacement) surgeries and for its RECLAIM Revision Femoral Hip System (cementless hip revision surgery). According to Mike Barker, the worldwide vice president of product development for DePuy, "This system has been studied extensively through analytic techniques and rigorous laboratory testing," quoted Ortho SuperSite. "The RECLAIM Hip System truly delivers a superb level of functionality and reproducibility for surgeons performing revision hip surgery," said David Floyd, worldwide president of DePuy. "We believe that the RECLAIM Hip Stem, in conjunction with our PINNACLE Acetabular Cup System, represents a meaningful advance in revision hip surgery," added Floyd, quoted Ortho SuperSite.

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.

Call Sullivan Brill @ 212-566-1000

Office Locations

New York

Trinity Centre
115 Broadway, 17th Floor
New York, NY 10006
(212) 566-1000

Puerto Rico

 #73 Santa Cruz St., Suite 407
Santa Cruz Medical Building
Bayamon, Puerto Rico