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According to allegations raised in a recently filed product liability lawsuit, problems with the Stryker Trident Tritanium Acetabular Cup hip replacement system caused Texas woman to experience complications, which ultimately resulted in the need for revision surgery after the hip system failed.
The complaint (PDF) was filed by Linda Kay Benton in the Superior Court of New Jersey for Bergen County on August 15, naming, Howmedica Osteonics Corporation, doing business as Stryker Orthopaedics, and a number of unnamed manufacturers, wholesalers, sellers, distributors and marketers, as defendants.
Benton indicates that she received the implant for as part of a left hip replacement in October 2014. However, she later began experiencing discomfort and, required revision surgery to have the implant removed in January 2018. During the removal, surgeons discovered that the acetabular liner and two screws within the cup had come loose.
The Stryker Tritanium Acetabular Cup was approved by the FDA in July 2008, and was fast-tracked through the agency’s controversial 510(k) approval system, meaning it only needed to be “substantially equivalent” to an existing implant for approval.
The lawsuit notes that there are more than 200 complaints about problems with the Struker Tritanium Acetabular Cup (TAC) in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, with more than 130 of those complaints involving reports of loosening or implant migration.
In addition, reports of these issues have been reported at orthopedic conferences for some time. Benton’s lawsuit claims it is clear Stryker knew about the problem but failed to address it or warn doctors or their patients about the risks.
“Sales Representatives of Defendant Stryker have attended numerous revision surgeries where the Tritanium Device was removed by surgeons due to loosening, and Defendant has taken the failed hip for analysis to assess why it was prematurely failing,” the lawsuit notes. “Defendants have been aware of the Tritanium Device’s dangerous propensity for early failure due to acetabular aseptic loosening for a significant period of time.”
The lawsuit notes that several studies have warned about potential problems with the implants as well.
In November 2018, Stryker agreed to settle hundreds of similar LFit V40 hip implant lawsuits filed in federal courts nationwide. A Stryker LFit v40 recall was issued in late 2016, following reports of taper lock problems, which may result in pain, inflammation, loss of mobility, disassociation and the need for risky revision surgery.
Several other manufacturers faced similar hip replacement failure lawsuits in recent years, claiming that the designs were unreasonably dangerous and prone to early failure. Similar allegations led to DePuy ASR hip lawsuits, DePuy Pinnacle hip lawsuits and other cases.