Stryker Rejuvenate Hip System Recalled: Lawsuits on the Horizon
On July 6, 2012, orthopedic products manufacturer Stryker issued a voluntary hip recall for its Rejuvenate Modular and ABG II hip implants. These devices have been associated with a range of complications, including corrosion of the implant and deterioration that may lead to pain and early revision surgery. Corrosion of the implant may lead to metallosis of the surrounding tissue. This is Stryker’s second recall of 2012. In April, Stryker issued a recall for the Accolade femoral stem due to high revision rates.
The FDA approved Stryker’s products on June 3, 2008 in a 510(k) submission for a line extension of the Stryker Modular Hip System which was approved in September 2007.
The first lawsuit regarding the recall was filed on August 7, 2012 in the Bergen County Superior Court of New Jersey. According to the complaint, plaintiff had a Stryker Rejuvenate implanted during a hip replacement surgery in October 2011. Shortly thereafter, the plaintiff began to experience pain and discomfort around the surgical site. Testing did not reveal any evidence of implant loosening or infection.
After continuing with her daily life, the plaintiff’s pain and discomfort continued. Further testing showed that a pseudotumor and possible fluid buildup had developed near the implant. Plaintiff was advised that a revision surgery of the Stryker hip was necessary to fix the problem. During the surgery, it was discovered that not only did the plaintiff have a pseudotumor, but she also had developed soft tissue necrosis, bony tissue necrosis and metallosis.
The plaintiff’s lawsuit alleges that Stryker failed to timely report adverse events and information concerning product failures. The suit brings counts of negligence, failure to warn, breach of express warranty, and manufacturing defect.