Lawsuits against Stryker Orthopaedics over its recalled Rejuvenate Modular Hip Implant System continue to mount. This week, the medical device maker was named in two Florida lawsuits alleging Stryker Rejuvenate hip replacements resulted in metal poisoning that caused bone and muscle tissue surrounding the devices to corrode.
Stryker Orthopaedics recalled its Rejuvenate and ABG II modular hip stems and ceased global distribution of the products on July 6, after continued post-market surveillance indicated the devices may be prone to “fretting and/or corrosion at or about the modular-neck junction. Both hip implant systems consist of a chromium-cobalt stem, a titanium neck and a non-metallic ball. While they are not technically considered “metal-on-metal” hip implants (such devices consist of a ball and cup both made from a chromium/cobalt alloy), evidence is growing that modular metal hip systems can cause the similar metal-poisoning issues seen with metal-on-metal hip replacement designs.
When Stryker recalled the Rejuvenate and ABG II hip systems in July, the company warned that retting or corrosion at the modular -neck junction can lead to pain, swelling and adverse reactions in surrounding tissue. Just two months before the recall, a study commissioned by Stryker found that metal modular hip systems may be associated with premature failure due to osteolysis, aseptic loosening and pseudotumor formation. The Stryker report advised that patients fitted with modular-neck hip implant systems who experience unexplained, persistent pain undergo medical evaluations that “should likely include serum metal ion levels, metal hypersensitivity testing and radiographic analysis including plain radiographs and preferably a metalartifact reducing MRI.” Similar advice has been given to patients implanted with metal-on-metal hip implant devices.
According to these two new lawsuits, which were filed in Broward County, Florida, both plaintiffs were forced to have their Stryker Rejuvenate hip implants surgically removed after they experienced symptoms indicative of heavy metal poisoning. According to a report from SunSentinal.com, these symptoms included damage to muscle and tissue, as well as the formation of tumor-like masses near the implants. The plaintiffs’ attorney told SunSentinal.com that both individuals experienced symptoms and failure of the device “faster than I’ve ever seen in a hip implant.”
Since the Rejuvenate and ABG hip systems were recalled, people from around the country have filed lawsuits seeking compensation for pain and suffering allegedly caused by the devices. Just last week, seven people charged in separate lawsuits that Stryker negligently tested, manufactured and distributed the Rejuvenate hip implant system. All of those complaints were filed in state court in Bergen County, New Jersey. Those claims joined one other filed in Bergen County last month that alleged the Rejuvenate system caused serious complications, including elevated metal ion levels, necessitating a difficult revision surgery to have the defective device replaced.