The Stryker LFIT V40 femoral head is used in the Stryker Accolade TMZF and Accolade 2, and the Citation and Meridian stems. Similar to issues with other metal-on-metal hip replacement devices, the Stryker LFIT reportedly has an increased risk of metallosis, which occurs when cobalt and chromium from the replacement device are absorbed by the tissue surrounding the implant and enter the patient's blood stream. But the LFIT allegedly has another serious issue: an increased risk of spontaneous dislocation or dissociation.
"The femoral head is supposed to connect with a metal cup," Dr. Malik says. "There is a connection between the head and the stem, which goes into the femur. But right at the juncture of the device's head and stem, there is metal corrosion that is similar to iron rust. This leads to degradation of the head and stem, which can then lead to spontaneous dislocation or dissociation."
Patients may suffer early symptoms that warn them of potential failure of the device—symptoms such as pain, swelling, and reduced mobility. But Dr. Malik says there are also catastrophic cases of spontaneous dislocation, in which a minor movement causes the head to snap off the device leading to an emergency medical situation.
"In some cases, the spontaneous dislocation and snapping off of the head may be the only initial symptom," Dr. Malik says. "It could be that there are no symptoms and then the patient needs emergency surgery and finds out the head has been corroding for some time."
"It could be that there are no symptoms and then the patient needs emergency surgery and finds out the head has been corroding for some time."
Lawsuits have been filed against Stryker, alleging the femoral head was defectively designed. According to Dr. Malik, the company has issued a quiet recall, encouraging doctors to follow up with patients. Health Canada has issued a recall on certain units of the devices, (8/24/16) but the US Food and Drug Administration has not done so. In issuing its recall, Health Canada noted Stryker had "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."
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For patients who have suffered a failure of their hip implant device, litigation is in early stages meaning it is not too late to file a lawsuit. Stryker and other metal-on-metal hip replacement makers have faced lawsuits in the past, with some settling those lawsuits.
"Stryker's Rejuvenate [which was recalled in 2012 after reports indicated an increased risk of failure] was supposed to be revolutionary—their premier product," Dr. Malik says. "There were 20,000 implanted nationwide, but ultimately they faced lawsuits and settled for $1.4 billion. Patients who have had problems with their hips and received an implant containing the Stryker LFIT should contact an attorney for further information. They may be eligible for compensation."