After the Australian government issued a warning about Stryker's LFIT Anatomic CoCr V40 femoral heads, physician/lawyer Shezad Malik believes a recall could be "imminent," Qmed reports.
Here's what you need to know.
1. The femoral heads are used in the Accolade TMZF, Accolade 2, Meridian and Citation stems. The heads were all manufactured before 2011.
2. The Australian government issued the hazard alert because adverse events were associated with the hip replacement part. The government said the heads "have a higher than expected incidence of taper lock failures."
3. Several U.S. law firms have written posts on the cobalt-chromium femoral heads as well, with one lawyer saying a physician had received a multiple page list with defective lots indicated. The lawyer is not releasing the list "for fear of releasing the surgeon-recipient's name."
4. The FDA has not issued any alerts related to the Stryker products, but its MAUDE database has more than 100 adverse effects associated with the LFIT Anatomic CoCr V40 head specifically.
Some of the adverse effects include severe pain or "noticeable limb shortening."
5. Stryker previously recalled 5,600 implants in 2008 because of an increased risk of stem neck fractures when the "V40 +16mm offset femoral head was used with certain Accolade TMZF femoral stems in overweight or obese patients."
6. Stryker is in the process of paying more than $1.4 billion to settle lawsuits related to its Rejuvenate and ABGII artificial hips, which were recalled in 2012. The company warned that the implants could damage tissue around the hip and cause health problems.
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