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According to allegations raised in a recent product liability lawsuits, problems with a Stryker Accolade TMZF hip stem and L-Fit V40 femoral head caused a Minnesota main to experience catastrophic failure of his artificial hip implant.
The complaint (PDF) was filed earlier this month in the U.S. District Court for the District of Minnesota, indicating that James Smith the components in 2007, and subsequently required revision surgery to remove the Stryker hip replacement.
Smith received a combination of the Stryker Accolade TMZF hip stem, together with a Stryker LFit Anatomic V40 chromium/cobalt head, which has since been recalled due to a higher-than-expected number of reports involving problems with trunnion failure, metal wear, adverse tissue reactions and other complications resulting in the need for revision surgery. The complaint indicates that Smith experienced each of these hip complications.
“After the implantation of the Defective Devices, Plaintiff James M. Smith began experiencing discomfort in the area of his Defective Devices. He also developed an audible clunk in the hip when he walked,” the complaint states. “Initial diagnostic workup revealed gross failure of the Accolade trunnion and marked elevation of serum cobalt, chromium and titanium.”
A Stryker LFit V40 recall was issued by the manufacturer earlier this year, impacting certain large-diameter femoral heads manufactured before 2011, which feature a chromium and cobalt composite.
“Had Plaintiff or his surgeon received a proper or adequate warning as to the risks associated with using the Accolade and L-Fit Anatomic V40 heads, the products would not have been used,” according to allegations presented in the complaint. “Reasonable and adequate alternatives to chromium/cobalt femoral heads existed at the time Plaintiff was implanted with his
“Had Plaintiff’s surgeon received a proper or adequate warning as to the risks associated with using the Accolade TMZF Stem and its combination with chromium/cobalt femoral heads, he would not have recommended the device; would have used an alternative device or at a minimum, provided Plaintiff with adequate warning and obtained his informed consent,” according to allegations presented in the lawsuit. “[H]ad Plaintiff received an adequate warning, Plaintiff would not have agreed to have the Accolade implanted or would have demanded that the Accolade be combined with a ceramic femoral head.”
The case joins a growing number of hip replacement lawsuits filed in recent weeks over problems with the Stryker Accolade and L-Fit V40 combination, each raising similar allegations. In addition, as more individuals receive Stryker recall letters or learn they received a recalled L-Fit V40 femoral head, it is likely that hundreds, if not thousands of additional complaints will be filed in the coming weeks and years.