JPML Establishes Stryker MDL in June
Joint replacement device manufacturer Stryker Orthopaedics previously recalled two of its hip replacement devices due to high failure rates, according to the company’s official website. This recall was announced after post-marketing surveillance data showed that the hip replacement systems may cause complications that could significantly increase the likelihood of hip failure. Since then, numerous Stryker hip recall lawsuits have been filed against the company, claiming that it had failed to properly warn consumers regarding the risks associated with its devices.
The hip replacement systems being referred to in the above paragraph are the Rejuvenate and ABG II modular hip replacement devices. These hip systems were certified by the U.S. Food and Drug Administration (FDA) in the year 2008 and 2009. Both devices were approved using the 510(k) approval process, which can allow untested medical devices to be distributed on the market, according to online sources. Following market release, the hip devices became extremely popular. This is most likely because the manufacturer promised long-lasting joint replacement devices that can give implant patients a better range of motion compared to other similar hip systems. According to Stryker, the hip devices offer orthopedic surgeons the option to custom fit implant patients according to their anatomy.
Despite the popularity of the above hip replacement systems, several reports of implant patients suffering from complications associated with the Rejuvenate and ABG II hip devices were submitted to the FDA. According to such reports, some of the affected patients had to undergo hip revision surgery in order to alleviate their complications. Many of them reportedly claimed to have sustained permanent injuries.
Just like many other metal-on-metal (MoM) hip replacement devices, the Rejuvenate and ABG II hip systems have been linked to complications associated with metal toxicity. Such complications may include metallosis, cobalt poisoning, tissue necrosis, and bone loss.
Several implant patients affected by the above complications have filed a lawsuit against Stryker, demanding compensation for all the damages they have suffered. Due to the large volume of lawsuits pending in courts, reports say the Judicial Panel on Multidistrict Litigation has established a Stryker multidistrict litigation on June 12, 2013.
http://www.mnd.uscourts.gov/
http://www.stryker.com/en-us/
