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A product liability lawsuit filed by a Rhode Island couple indicates that problems with recalled Stryker LFit V40 femoral head with an Accolade hip stem resulted in the formation of a pseudotumor, which resulted in the need for revision surgery to remove the artificial hip.
The complaint (PDF) was filed by Arthur Smith and his wife, Sarah, in the U.S. District Court for the District of Rhode Island on May 26, indicating that Homedica Osteonics and it’s Stryker subsidiary marketed the combination of hip components, which have been reported to cause corrosion and the development of hip pseudotumors.
Arthur Smith underwent a left hip replacement, where a Stryker LFit V40 femoral head and Stryker Accolade TMZF Stem were implanted in his body. After experiencing pain and discomfort around the implant, Smith indicates that an MRI revealed a pseudotumor in his left hip.
As a result of the findings, Smith underwent hip revision surgery in August 2014, at which time the surgeon noted a “hard, firm peach size pseudotumor”, which involved metallosis, a form of metal blood poisoning, around the trunnion and the head. The implant was replaced with a ceramic one to prevent further metal blood poisoning from cobalt and chromium debris shed by the Stryker LFit and Accolade hip components.
After receiving similar reports of problems, a Stryker LFit v40 hip recall was issued last summer by the manufacturer, 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.
“Patients in whom Stryker Rejuvenate and ABG II hip stems had been implanted were experiencing device failure, symptoms and diagnostic findings similar to Plaintiff, Arthur D. Smith. Information disseminated by Stryker at or about the time of the recall cited this failure mechanism as the reason for the recall,” the lawsuit states. “Since the recall, revision rates for the Rejuvenate and ABG II have been reported to exceed 50% in a very short period of time.”
The Smiths present claims for common law negligence, failure to warn, design defect, manufacturing defect, breach of warranty and loss of consortium, seeking both compensatory and punitive damages.
The case filed by Smith now joins a growing number of other product liability lawsuits filed in recent months by those who have suffered complications due to Stryker Accolade and LFit V40 hip components.
As hip replacement lawyers continue to review cases for individuals who are just now learning that complications experienced in recent years may have been caused by design problems, it is expected that several thousand lawsuits may be filed in the coming months and years.