In July 2012, Stryker Orthopaedics issued a voluntary recall of two of its hip replacement products, the Rejuvenate Modular and the ABG II. This recall came just years after the FDA approved the Rejuvenate device in June 2008 device and the ABG II device in November 2009. On its website, Stryker explained that the recall was issued “due to the potential for fretting and corrosion at the modular neck joint.” Both of these products were designed using the metal-on-metal method, which the FDA has expressed concerns about. Specifically, the FDA has stated concerns about the potential for corrosion and the release of metal ions from these devices.
According to the FDA, metal-on-metal hip replacements like Stryker’s Rejuvenate Modular or ABG II may cause side effects like swelling, pain, infection, osteolysis, device loosening, fracture, or dislocation. Like any joint implant, the components of a metal-on-metal slide against each other. However, metal-on-metal may create metal particles when the components slide against each other. In addressing this issue the FDA states that “Different people will react to these metal particles in different ways. At this time, it is not possible to predict who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be.”
The Stryker infographic provides a list of possible side effects as well as providing information about FDA warnings and alerts to Stryker.
“We hope this infographic raises patient awareness about metal-on-metal implants. Patients implanted with these devices should talk to their doctors about tests, treatments, or surgeries that may be necessary to discover and correct any damage that may have been caused by such an implant,” said attorney Paul d’Oliveira. “I believe that metal-on-metal implants have become such a growing area of litigation because the FDA’s approval process does not require the testing necessary to ensure patient safety.”
If you or a loved one has experienced pain, fracture, dislocation, or device failure from a Stryker hip replacement, you may want to speak with a personal injury lawyer regarding a potential claim. d’Oliveira & Associates is working with some of the leading Stryker lawyers in the country who are handling these cases.
Please contact the law offices of d’Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.