Hip Replacement Devices
According to the FDA, over 400,000 hip replacement (arthroplasty) surgeries are performed in the United States every year.
In recent years, data from both medical publications and registries that track medical device safety have raised questions concerning the potential safety of metal on metal hip replacement systems, including concerns of ALVAL (aseptic lymphocytic vasculitis-associated lesions) and pseudotumors from the metal shavings, earlier than expected revisions of the surgery and exposure to increased levels of metal ions, including cobalt.
Much of these concerns began in 2010, with the removal of Depuy ASR hip replacement system from the market. Since that time, there have been other metal on metal hip replacement systems taken off the market or subject to similar concerns.
In May 2011, the information developing on metal on metal hip replacement devices and other hip replacement products caused the FDA to request that all manufacturers of this devices to conduct safety studies on their products to determine product safety. The May 2011 request from the FDA can be found here.
Then, in late June 2012, a panel consisting of experts from the scientific and clinical disciplines was empaneled by the FDA to study the risks and benefits of the metal on metal hip systems. The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee has posted a website with more information.
In response to this on-going debate, The American Academy of Orthopaedic Surgeons has also issued guidance to its members concerning these products. You can read that information here.
Mike Sudekum and his firm, Mandel & Mandel, LLP, are currently investigating claims for patients who received a metal on metal hip replacement or similar device. Some of the signs that might indicate an issue include:
- Revision surgery
- Recommendation for revision surgery
- Metallosis (define)
- Corrosion of the implant
- Elevated cobalt levels, or (define – what are the problems), and
- Increased pain in the leg, hip or groin.
In some cases, these symptoms are unrelated to the device; however, if you have received a hip replacement system from one of these manufacturers, you may have a claim.
Some of the devices that may contribute to these conditions include:BioMet M2a Magnum
- Zimmer Durom Hip Cup
- Wright Medical Conserve
- Wright ProFemur Hip System
- Stryker Rejuvenate Modular Hip System
- Smith & Nephew
- DePuy ASR
- DePuy Pinnacle
If you have experienced these conditions following hip replacement or underwent a revision, hip replacement attorney Mike Sudekum will investigate these claims on your behalf. You may contact him here.