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According to allegations raised in a product liability lawsuit filed by a woman who experienced problems with a Stryker metal hip, design defects with the Accolade hip stem and LFit v40 femoral head caused debris to be released into her body, resulting in metal blood poisoning and failure of the hip replacement less than ten years after it was implanted.
The complaint (PDF) was filed by Linda Regan in the U.S. District Court for the District of Massachusetts on February 22, indicating that Howmedica Osteonics Corp., doing business as Stryker Orthopaedics, manufactured and sold hip replacement components that were prone to release metal ions into patients’ blood. As a result, users face a high risk of catastrophic failures, often resulting in the need for risk hip revision surgery, according to the lawsuit.
Regan underwent hip replacement surgery in July 2007, at which time a Stryker Accolade TMZF Hip Stem was implanted together with a Stryker LFit Anatomic v40 Femoral head, which was ultimately recalled last year amid reports of metal blood poisoning problems.
After the Stryker metal hip components were placed into her body, Regan indicates that she began to experience pain and discomfort. Diagnostic workup failed to find any evidence of hip loosening, infection, malposition or other explanation for her symptoms, according to the complaint. However, it was subsequently discovered that there were “markedly increased levels of metal ions” in Regan’s blood.
As a result of the Stryker hip replacement metal blood poisoning, and continued worsening of her symptoms, Regan underwent hip revision surgery in July 2014, at which point it was noted by her surgeons that there was significant metallosis and trunnionosis in her hip, resulting in soft tissue damage. The doctor also found that there was corrosion at the taper junction between the Stryker Accolade hip stem and Stryker L-Fit v40 chromium and cobalt femoral head.
Due to similar reports of problems, a Stryker LFit v40 hip recall was issued by the manufacturer last year, impacting certain large-diameter femoral heads sold before 2011. At that time, Stryker acknowledged that a higher-then-expected number of individuals were experiencing problems with trunnion failure, metal wear, adverse tissue reactions and other complications.
“Plaintiff is informed and believes, and thereon alleges, that the problems with the V40 head/Accolade Stem combinations are much larger than those referenced in the [Stryker recall notice] and are caused by the metallurgical formulation used to manufacture the TMZF Accolade Stem and/or the geometry of the Cobalt/Chromium V40 Head,” according to the complaint filed by Regan. “Plaintiff alleges that all V40 heads sold by defendants are defective and should recalled. Instead the Stryker defendants have intentionally downplayed the risk of harm and limited the scope of its recall in an effort to hide from surgeons, patients and the FDA the true extent of the problems with their defective hips.”
The case joins a growing number of similar Stryker Accolade hip replacement lawsuits filed in recent months over metal blood poisoning problems.
Although plaintiffs indicate that a simple, inexpensive blood test could be used to help determine whether individuals are experiencing the corrosive process that leads to metal poisoning and the recent recall, specifically the presence of elevated levels of cobalt, chromium or titanium in the blood, lawsuits indicate that Stryker failed to provide adequate warnings or instructions to surgeons.
As a result, hip replacement lawyers are not only pursuing similar cases for individuals who have required revision surgery, but are also reviewing claims for individuals with recalled Stryker hip components in their body, which may be releasing toxic levels of metal without any knowledge that their hip replacement is corroding.