More than a half dozens lawsuits have been filed over the recalled Stryker Rejuvenate modular hip implant system by plaintiffs who experienced pain and discomfort, allegedly due to metal poisoning which resulted from fretting or corrosion of the devices’ metal components. According to the complaints, all of the plaintiffs underwent corrective revision surgery in as little as eight months after receiving their Stryker Rejuvenate metal hip implant.
The Rejuvenate Hip Replacement System consists of a chromium-cobalt stem, a titanium neck and a non-metallic ball. As we reported previously, 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. According to Stryker, fretting or corrosion at the modular -neck junction can lead to pain, swelling and adverse reactions in surrounding tissue.
Neither Stryker device is considered a “metal-on-metal” hip replacement system, in which the ball and cup are both made of cobalt and chromium. However, Stryker released a report in May that found metal, two-part modular-neck systems like the Rejuvenate and ABG II may cause many of the same problems seen with metal-on-metal hip implants, including 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.”
According to a report from NorthJersey.com, seven plaintiffs have charged in separate lawsuits that Stryker negligently tested, manufactured and distributed the Rejuvenate hip implant system. According to the complaints, which were all filed in New Jersey Superior Court in Hackensack, Bergen County, the plaintiffs all received Stryker hip implants between 2009 and 2011. Soon after, they each began experiencing pain and discomfort, and underwent tests that revealed their implants were loosening and dislocated. They all were forced to have revision surgeries which revealed metal toxicity, evidenced by the “presence of milky, turbid fluid; large pseudotumor formation; soft tissue necrosis; muscle loss and/or bony necrosis at the proximal femur.”
A total of eight lawsuits have now been filed in Bergen County, New Jersey, on behalf of alleged victims of Stryker’s Rejuvenate hip implants. The first was filed by a Florida woman who alleged the Rejuvenate system 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.
According to attorneys representing victims of Stryker hip implants, thousands of people have been notified that their recalled hip may be putting them at risk for serious complications. Yet Stryker has given no assurance that it will pay to have the defective hip replacement devices removed and replaced.