Stryker’s recalled Rejuvenate and ABG II Modular-Neck Hip Implant Stems are prone to early failure and metal corrosion that put hip replacement patients at risk for suffering from adverse tissue reactions, including metallosis.
The national law firm, Parker Waichman LLP, is warning hip replacement patients of the potential for corrosion and adverse local tissue reactions linked to Stryker’s recently recalled Rejuvenate and ABG II Modular-Neck Hip Implant Stems. A report released by Stryker this May, indicated that these devices—modular metal neck stems—are prone to corrosion. This corrosion can lead to both adverse local tissue reactions and “premature failure due to osteolysis, aseptic loosening, and, in some instances, a devastating pseudotumor formation.”
In an announcement this July, Stryker stated that it issued a recall of its Rejuvenate and ABG II Modular-Neck Hip Implant Stems and was ceasing global production of the devices after post-market surveillance indicated that the products were prone to corrosion and fretting that may lead to adverse local tissue reactions. Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis, Stryker said.
The recalled Stryker Rejuvenate and ABG II hip implant components are two-part modular-neck systems consisting of a metal neck within a metal state. The Stryker report released in May advised that patients fitted with modular-neck hip implant systems who experience persistent pain not linked to an infection or other explainable cause should undergo medical evaluations. Assessments “should likely include serum metal ion levels, metal hypersensitivity testing and radiographic analysis including plain radiographs and preferably a metalartifact reducing MRI,” the report stated.
The problems linked to modular-neck hip implant systems, such as Stryker’s Rejuvenate and ABG II components, are significantly similar to problems seen in patients implanted with metal-on-metal hip replacement devices. In those devices, the hip implant’s ball and socket is made entirely of metal. Various studies have revealed that patients implanted with metal-on-metal hip implants may face an increased risk of developing serious complications such as tissue damage, device failure, the need for revision surgery, and long-term disability, all due to the corrosion and shedding of metal ions from the implants’ metal components.
In fact, this February, the British Medical Journal (BMJ) advised the public about potentially high levels of metallic ions being released by all-metal hip implants. In March, study authors of research published in The Lancet called for a ban on the devices after discovering that metal-on-metal implants failed at significantly higher rates than their ceramic and plastic equivalents. In May, the Journal of Arthroplasty published a study showing that metal-on-metal implants corrode faster than metal-on-polyethylene implants and, recently, a study published in Chemical Communications revealed potential evidence of genotoxicity in metal hip patients who experienced inflammation and the need for subsequent revision surgery.
Last month, a U.S. Food & Drug Administration (FDA) report revealed that the agency’s review of recent data suggests that metal-on-metal hip replacement systems are likelier to fail when compared to other hip implant devices and also said that some 16,800 adverse event reports from 2000 to 2011 were received concerning these devices. In just 2011, metal-on-metal hip implant complaints made to the agency totaled 12,137, compared with about half that—6,332—concerning other types of hip replacement systems. Most adverse events reported to the FDA in the past decade involved revision surgery to remove a failing metal-on-metal hip implant.
Last month, at two day meeting about metal-on-metal hip implant safety, the FDA’s Orthopaedic and Rehabilitation Devices Panel advised that metal-on-metal hip replacement recipients who were experiencing symptoms indicative of implant failure should undergo X-rays, MRIs, and CT scans to detect abnormalities and, possibly, blood testing for metal ions. The panel also recommended regular X-rays for all patients, regardless of symptoms and called for additional warnings to be placed on the labels of all-metal implants.
The devices have been the focus of mounting lawsuits and more are expected.