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Headquartered in Kalamazoo, Michigan, Stryker Orthopaedics is one of the world’s largest medical device companies operating in the global orthopedic market. As mentioned in our October 16, 2016 blog post, Stryker Orthopaedics issued an urgent voluntary medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with several models and brands of hip replacement products including the Stryker Accolade Hip replacement system. The Urgent Medical Device Recall Notification specifically related to LFIT V40 Femoral Heads manufactured prior to 2011.The femoral heads are used with the Stryker Accolade stem and have shown a high rate of failure causing patient injuries including loss of mobility, pain, inflammation, adverse local tissue reaction, dislocation, joint instability, broken bones around the components, leg length discrepancy, and a need for complicated and painful revision surgery.
The Urgent Medical Device Recall Notification advises doctors that Stryker has received a higher than expected number of complaints for its LFIT Anatomic CoCr V40 femoral heads. Based on the information Stryker has received, Stryker notified surgeons of potential health hazards and problems with the recalled devices, including disassociation of the femoral head from the hip stem, hip stem fractures, excessive metallic debris in the bloodstream, insufficient range of motion, loss of implant/bone fixation strength, excessive wear debris, insufficient tissue tension, and noise.
Stryker’s recall notification did not provide information regarding follow-up treatments for patients implanted with the recalled LFIT V40 femoral stems. However, a patient who has a recalled Stryker hip implant can find out if their device may be failing by his or her doctor to take a blood test to check cobalt and chromium levels in the body. Elevated cobalt and/or chromium levels may indicate that a patient’s Stryker hip implant is defective because it is releasing metal ions at the junction between the LFIT V40 femoral head and the stem component, potentially requiring a revision surgery to remove and replace the failed hip replacement system and component.
The new Stryker LFIT V40 recall is not limited to the United States:
On August 24, 2016, Health Canada, the Canadian public health agency, issued a recall notification to the general public, healthcare professionals and hospitals regarding certain models of the LFIT CoCr V40 femoral heads. The notification stated that “Stryker has received higher than expected complaints of taper lock failure for specific lots of certain sizes of LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011.” The taper lock is the part of the hip implant component that connects the femoral head to the femoral neck. Failure of the taper lock can result in a complete loss of movement, severe pain, instability of the entire joint, bone fracture, dislocation as well as other significant problems. Revision surgery will generally be required to repair any complications resulting from taper lock failure. Surgery will not repair the complication in all cases and such patients may be left permanently disabled.
On September 27, 2016, the Australian Government Department of Health published a Hazard Alert regarding the risk of injuries relating to the Stryker LFIT V40 femoral head hip implant components, citing the same dangers as the U.S. and Canada recalls, and warning consumers and health professionals about the higher than expected incidence of failures and injuries relating to Stryker LFIT V40 hip implant components.
These new recalls of the defective LFIT V40 hip implant component may lead to a large number of new lawsuits in addition to those already filed against Stryker over the past few years. Stryker and its New Jersey-based subsidiary, Howmedica Osteonics, recalled its Rejuvenate Modular and ABG II modular-neck hip stem implants in July 2012 due to fretting and/or corrosion of the modular neck junction and cobalt and chromium debris, which resulted in premature implant failure, metal poisoning (metallosis) adverse tissue reactions, bone death (necrosis), osteolysis and other painful medical conditions. The metal-on-metal hip implant failures required many hip implant patients to undergo painful and costly revision surgery to remove and replace the defective implants. Thousands of Stryker hip implant patients sued the company for damages alleging defects and failures of the Stryker Rejuvenate and ABG II hip implants. The lawsuits were consolidated into a multidistrict litigation (MDL) in Minnesota federal court in 2013 to resolve common issues among the cases (In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, MDL No. 2441).
If you or a family member have a hip implant, or have had revision surgery to remove and replace a hip implant, you and/or your family member may be entitled to money damages.