Medical Device MDL Status: Stryker

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The following is the status of pending multidistrict litigation (MDL) involving major orthopedic medical device manufacturer, Stryker/ HowmedicaOsteonics Corp.:

2441 IN RE: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation
District of Minnesota (Hon. Donovan W. Frank)

In November 2014, Stryker Orthopaedics settled approximately 3,000 Rejuvenate Hip Stem and ABG II Modular Hip Stem lawsuits in New Jersey’s Bergen County Superior Court, the 17th Judicial Circuit Court of Florida, the 15th Judicial Circuit Court of Florida, and the MDL. Pursuant to the settlement, Stryker agreed to pay hip implant patients a base award of $300,000 for each revised hip, with additional compensation for patients who had complications during revision surgery to remove the hip implant. Stryker has advised the court that 95% of additional registered eligible patients have enrolled in the 2016 Settlement Program, which means that Stryker will provide compensation to additional eligible U.S. patients who had revision surgery to replace their Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem prior to December 19, 2016.

The hip replacement implant failures at issue relate to the use of metal-on-metal hip implants, or hip implants with increased use of metallic parts intended to withstand greater wear and enhance lifespan profiles. Unfortunately, these implants have actually failed early due to metal blood poisoning, or metallosis (which occurs when high levels of chromium and cobalt ions shed as debris from friction between the components enter the surrounding tissue and bloodstream), inflammation of surrounding tissue, or loosening of components which threatens patients’ stability and mobility.

2768 IN RE: Stryker LFIT V40 Femoral Head Products Liability Litigation
District of Massachusetts (Hon. Indira Talwani)

In April, the United States Judicial Panel on Multidistrict Litigation (JPML) ordered the transfer of 33 pending federal lawsuits from 17 district courts, along with all future claims, asserting injury caused by HowmedicaOsteonics Corp.’s Stryker-branded LFIT Anatomic CoCR V40 femoral heads, a prosthetic hip replacement device, to the United States District Court for the District of Massachusetts. The initial status conference took place on May 16th for which Judge Talwani asked counsel in the lawsuits to file a status report identifying pending motions, including those to remand or dismiss, and specifying the state whose laws may govern said action.

Stryker’s LFIT V40 Anatomic CoCr Femoral Heads are made of a cobalt and chromium alloy and were designed to offer surgeons the intra-operative flexibility to better match patient anatomy and restore natural movement to enhance hip stability, minimize dislocation and maximize range of motion. The heads are used in combination with several of modular hip implants, including Accolade TMZF, Accolade 2 Stems, Meridian Stems, and Citation Stems. More than 100,000 LFIT V40 components may have been implanted in patients

Stryker issued an urgent voluntary medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Heads manufactured prior to 2011. Potential hazards listed in the recall notice included excessive metal debris, disassociation of the head from the stem/failure, trunnion fracture, and corrosion at the femoral head and stem junction.

Filed lawsuits allege that the titanium material of the hip stem did not maintain structural integrity when used with the chromium and cobalt V40 femoral heads, thereby causing disassociation of the head from the hip stem, hip stem fractures, high levels of metallic debris in the bloodstream (metallosis), poor range of motion, loss of implant and/or bone fixation strength, debris from excessive wear, low tissue tension and noise. Accordingly, patients suffered injuries including loss of mobility, pain, inflammation, adverse local tissue reaction, dislocation, joint instability, broken bones, leg length discrepancy, which necessitated painful revision surgeries.

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