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Following a letter sent several months ago about a high rate of failures and problems with Stryker LFit V40 femoral head hip implant components, Canadian health officials announced a recall of the medical device. However, months later, there still has been no official recall announcement issued in the United States.
Stryker sent out an urgent field action notice (PDF) in August, which many have described as a Stryker hip recall, as medical providers were told to quarantine and return certain LFit Anatomic CoCr V40 Femoral Head components manufactured prior to 2011.
The statement warns about a risk of “potential hazards” associated with a failure at the point where the femoral head connects to the femoral neck, which can cause individuals to experience extreme pain, problems walking and result in the need for hip revision surgery.
Around the same time Stryker issued this letter, Health Canada appears to have announced an official Stryker LFit CoCr V40 femoral head recall.
“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 Health Canada recall notice warns..
In September, Australian health officials also passed on Stryker’s warning to doctors and patients, urging doctors to follow up with patients who had been implanted with the affected component.
Despite the apparent widespread use of the Stryker LFIT V40 hip implant, as of early October, there does not appear to have been any announcement that the Stryker LFit V40 was recalled by the FDA in the U.S., and not even an announcement about Stryker’s warning letter has been issued to individuals who may have the component as part of their Stryker hip replacement.
A number of individuals who have experienced problems are now considering potential Stryker LFIT V40 hip lawsuits, as well as Stryker Accolade hip lawsuits, as the femoral head component was frequently used with the Accolade hip stem. The manufacturer faces claims for designing and selling an unreasonably dangerous and defective medical device, and failing to issue a worldwide recall as soon as it became apparent that these devices fail at an alarming rate.
It is unknown at this time what, if any, actions U.S. regulators will take as a result of the Stryker hip implant problems.