Medical device failures have been known to happen; however, hip implants are quickly becoming the largest medical device failures in recent medical history. According to the FDA database, out of the six top manufacturers, three manufacturers’ stand out in hip implant or implant component recalls.
In 2010, Johnson & Johnson announced it was recalling two kinds of its hip implants made by DePuy Orthopaedics, a unit of Johnson & Johnson. The two recalled implant systems, the ASR Hip Resurfacing System and the ASR XL Acetabular System, were the two most commonly used DePuy hip implants systems. There is also significant litigation involving DePuy’s Pinnacle metal-on-metal Acetabular Cup System.
A number of orthopedic specialists consider the DePuy hip replacement systems to have had design flaws from the beginning and it is reported that they were approved by the FDA without the use of clinical trials.
In 2012, the Stryker Corporation, one of the world’s largest manufacturers of medical equipment and orthopaedic devices, recalled two of its artificial hip implant systems — the Rejuvenate Modular and ABG II Modular-Neck Hip Stems. The potential hazards included fretting and corrosion in and around the modular neck junction which could release excessive metal debris into the surrounding tissue, metal ions in surrounding tissues which could result in inflammation leading to an immunological response including metallosis (metal poisoning), necrosis (tissue and bone death) and pain. In addition, some studies have suggested links between the absorbed metal ions and neurological and heart problems, as well as damage to the lymph nodes, spleen, liver and kidneys. Cobalt is considered especially toxic.
In July 2008, Zimmer issued a brief U.S. recall for the Durom Acetabular Component, also known as the Durom Cup implant. Device failures were resulting from loosened components. Zimmer released new surgical instructions and allowed the device to remain on the U.S. market. The FDA recalled the devices in the fall of 2008 stating the hip implants were “misbranded” and called its labeling “false and misleading.” Zimmer continued to sell the implant. Complications occur when the implant loosens prematurely causing pain and swelling. Since it is a metal implant, the implant can also generate high levels of metal in the body, leading to damaged tissue and bone.
These hip implant systems have an unusually high early failure rate and costly and painful revision surgeries have been needed within a short time period. Even when these defective hip implants are removed and replaced, the revision surgery may leave dangerous –possibly deadly—fragments that may go undiagnosed for years.
Some common symptoms of a failed or failing hip implant may include:
If you’ve had a hip implant from any of the following and have questions about the product you received, please call us:
•Blomet •DePuy •Smith & Nephew •Stryker •Wright •Zimmer
It’s important that you do not sign any documentation the hip implant manufacturer may send you. If you’ve had hip replacement surgery, contact Goldstein, Buckley, Cechman, Rice & Purtz for a free consultation. We will explain your rights and work with you to seek a favorable outcome.
Goldstein, Buckley, Cechman, Rice & Purtz, P.A. has six offices in Southwest Florida. The offices are located in Fort Myers (two offices to serve you), Cape Coral, Naples, Lehigh Acres, and Port Charlotte for your convenience. Call us first at 800-332-9404 or fill out a simple case form today.