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A man who experienced complications with a Stryker L-Fit V40 femoral head used together with an Accolade hip stem has filed a product liability lawsuit, alleging that the cobalt/chromium femoral head should have been recalled much earlier.
The complaint (PDF) was filed by William D’Orlando in the U.S. District Court for the District of Massachusetts on November 8, indicating that he experienced metal blood poisoning, implant corrosion and required revision surgery after receiving a Stryker Accolade TMZF Hip Stem with an LFit V40 Femoral Head.
D’Orlando received the artificial hip implant in December 2009, and indicates that he began to feel discomfort, which led to a diagnostic work up of blood tests that found elevated levels of metal ions in his blood. As a result of the complications, he ultimately required revision surgery in April 2015, and indicates that he has had to undergo extensive rehabilitation.
“During this surgery, it was discovered that, in fact, there was significant evidence of heavy metal toxicity including the presence of copious amounts of cloudy fluid and severe adverse soft tissue reaction with significant soft tissue necrosis,” the lawsuit states. “His surgeon also noted the presence of corrosion at the taper junction between the Accolade and Stryker’s L-Fit V40 Chromium Cobalt femoral head.”
The case joins a growing number of Stryker LFit V40 lawsuits filed in recent weeks, since the manufacturer removed certain large-diameter versions of the femoral head from the market amid higher-than-expected reports of problems caused by the release of metallic debris. However, D’Orlando indicates that all V40 heads are defective and should have been recalled.
The Stryker LFit V40 recall was first announced as part of a hazard alert issued by Australia’s Therapeutic Goods Administration, indicating that certain large-diameter femoral heads manufactured before 2011 may experience taper lock failures, which can result in loss of mobility, pain, inflammation, adverse local tissue reactions, dislocation and the need for revision surgery, among other complications.
The action was taken after an investigative report published in the Journal of Bone and Joint Surgery in August 2016, which outlined five cases of catastrophic failure with Accolade/LFit V40 combinations, which noted that there was extensive corrosion in the V40 head and Accolade stem that caused the stem to fracture at the stem/head juncture.
“[P]roblems with the V40 head/Accolade Stem combinations are much larger than those referenced in the Stryker Defendants’ recall notice and are caused by the metallurgical formula used to manufacture TMZF Accolade Stem and/or the geometry of the Cobalt/Chromium V4 Head,” according to the complaint. “Plaintiff alleges that all V40 heads sold by defendants are defective and should be 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 problems with their defective hips.”
In 2014, at least five similar Stryker Accolade hip lawsuits were filed by individuals who experienced LFit V40 femoral head failures, alleging that the components were defectively designed and manufactured.
As more individuals learn that problems with Stryker Accolade/LFit V40 hip implants may be linked to the defective design of this component, it is expected that hip replacement lawyers will file a growing number of complaints in the coming months and years.