Stryker Orthopaedics may be facing a new wave of litigation over a recently recalled metal hip implant component. The Stryker LFIT CoCr V40 femoral heads were recalled in Canada. According to an Aug. 24, 2016 recall alert posted on Health Canada’s website, the recall was issued because “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 component has not been recalled yet in the United States.
Health Canada is not the only regulator to take action over the hip implant component. In Australia, a “hazard alert” issued Sept. 27, 2016 warned of adverse events due to potential taper lock failures. The taper lock is the part of hip implant that connects the femoral head to the femoral neck. The Therapeutic Goods Administration of the Australian Government Department of Health says that if this component fails, it can lead to mobility issues, pain, inflammation, adverse local tissue reaction, dislocation, joint instability, broken bones near the taper lock, leg length discrepancy and the need for revision surgery.
The Australian hazard alert states that Stryker has notified orthopedic surgeons about the risk of taper lock failures. According to the announcement, potential complications include dissociation of the femoral head from the hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of movement, insufficient soft tissue tension, noise from the implant, loss of implant, bone fixation strength, increased wear debris and implant construct with a shortened neck length.
Metal-on-metal hip implants have drawn attention over the years in light of high-profile recalls and litigation. The problem, experts say, is that the metallic surfaces of the implant rub together and release metal particles into the bloodstream and tissues nearby. This can lead to metal poisoning (metallosis), tissue death and other complications that ultimately force patients to undergo a revision surgery to remove the failed device.
In June 2012, Stryker recalled its Rejuvenate and ABG II modular-neck hip stems due to the risk of “fretting and corrosion” at the modular-neck junction. The company warned that this could lead to adverse local tissue reaction, pain and/or swelling at the hip joint. In light of these risks, Stryker said that surgeons should consider blood testing, cross section imaging and other clinical examinations on these patients even if they do not experience pain or swelling.