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According to allegations raised in a hip replacement lawsuit filed by a Florida man, problems with a Stryker Accolade TMZF femoral stem and LFit V40 femoral head caused elevated levels of metal ions in his body, and a build up of fluid around the artificial hip, resulting in the need for revision surgery to have the devices removed from both his hips just five years after they were implanted.
The complaint (PDF) was filed by Francis T. Hassett in the U.S. District Court for the Middle District of Florida on January 27, against Howmedica Osteonics Corp, doing business as Stryker Orthopaedics.
Hassett underwent a total right hip replacement in June 2009, and a total left hip replacement in January 2011, both involving the Stryker Accolade TMZF Plus and Stryker LFit V40 components, among others. However, following the procedures he began to suffer pain in both hips, his groin and buttocks.
A diagnosis later revealed that he suffered from elevated metal ions in his blood, a condition known as metallosis, and peritochanteric fluid collections in both hips, indicating that he was suffering adverse local tissue reactions to the implants.
The Stryker hip replacement problems allegedly caused Hassett to undergo bilateral revision surgery, due to metal blood poisoning and local reactions caused by the cobalt and chromium hip components. The right hip was removed in January 2016, and the left hip implant was removed in June 2016. Surgeons found that the components were corroded and that he was suffering from metallosis and adverse local tissue reactions during both surgeries.
A Stryker LFit V40 hip recall was issued last year, impacting certain large-diameter femoral heads sold before 2011, after the manufacturer acknowledged that a higher-than-expected number of individuals were experiencing problems with trunnion failure, metal wear, adverse tissue reactions and other problems.
Before the recall, Stryker had claimed that cobalt/chromium alloys used LFit V40 implants were compatible and resistant to corrosion and fretting when used with the titanium alloy used with the Accolade TMZF femoral stem, the lawsuit indicates.
“Despite Stryker’s claims, this material combination has been reported to cause corrosion,” the lawsuit states. “For decades, scientists have reported the occurrence of significant fretting and corrosion issues when dissimilar metals are combined. In its marketing and sale of the device, Stryker represented and warranted that its proprietary materials alleviate this problem.”
Hassett’s lawsuit joins a growing number of Stryker hip replacement lawsuits filed in recent months over problems with the Accolade and L-Fit V40 combination, each raising similar allegations. Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, a motion was filed last month to consolidate and centralize the Stryker hip recall cases before one judge for coordinated pretrial proceedings.