A Florida woman has filed a lawsuit alleging Stryker’s recalled Rejuvenate hip implant device caused serious complications, including elevated metal ion levels in her blood, which forced her to undergo a difficult revision surgery to have the Rejuvenate hip stem replaced. Additional complications related to the Rejuvenate hip implant have since required her to undergo additional surgeries, according to her lawsuit.
As we reported previously, Stryker recalled the Rejuvenate and AGB modular-neck hip stems and terminated 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,” which may lead to pain, swelling and adverse reactions in surrounding tissue. According to a report from NorthJersey.com, this new lawsuit, filed in New Jersey Superior Court, Bergen County, is the first to name the recalled Rejuvenate device.
The Rejuvenate hip implant consists of a chromium-cobalt stem, a titanium neck and a non-metallic ball. According to the complaint, the 66-year-old plaintiff received the Rejuvenate hip implant in October 2011 to replace her right hip. Within months of her surgery, she began experiencing pain. Though imaging tests ruled out an infection and indicated the Rejuvenate hip was placed properly, her blood tests indicated she had elevated levels of metal ions in her blood.
In June of this year, the Plaintiff underwent surgery to remove abnormal tissue, and have a revision stem inserted. During the insertion, however, her femur was fractured. She has since had additional surgeries, and is currently in a nursing home undergoing 8 weeks of rehab, NorthJersey.com said.
The Stryker Rejuvenate implant is different in design to DePuy Orthopaedics’ recalled ASR hip implant and other “metal-on-metal” devices in which the ball and cup are both made of cobalt and chromium. However, concerns are mounting that the Rejuvenate device may cause many of the same problems seen with metal-on-metal hip replacements. In May, Stryker released a report that found metal, two-part modular-neck systems like the Rejuvenate may cause the same types of adverse local tissue reactions that have been seen in patients who have received metal-on-metal devices. Such reactions often result in “premature failure due to osteolysis, aseptic loosening and in some instances a devastating pseudotumor formation,” the report said. The Stryker report advises 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.”