Canadian medical regulators have already announced a Stryker hip recall for certain LFIT V40 femoral heads that have been linked to a high rate of hip replacement failures. While Stryker Othopaedics would go on to issue an Urgent Field Action Notice just days later, the devices have yet to be recalled in the U.S.
“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,” Health Canada warned in a recall notice dated August 24, 2016.
Stryker’s own notice, issued just five days later, warned that the affected hip components could be associated with various hazards, including:
In September, Stryker’s Urgent Field Action Notice prompted Australian regulatory officials to issue a Health Hazard Alert in that country.
It’s not known what – if any—action the U.S. Food & Drug Administration will take in relation to Stryker’s notification. However, Becker’s Spine Review is reporting that the agency’s MAUDE database lists more than 100 adverse effects associated with the LFIT Anatomic CoCr V40 head specifically, including some that cite pain and limb shortening.
Stryker’s LFIT Anatomic CoCr V40 Femoral Heads are constructed of a chromium/cobalt alloy, and are designed to be used with a number of modular hip components, including:
Stryker has identified the taper lock issue in four products, while three others with similar specifications have been included in the company’s notification as an added precaution:
According to Becker’s Spine Review, Stryker previously recalled 5,600 implants in 2008 due to 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.”
In Jul 2012, Stryker recalled its Rejuvenate and ABG II hip stems, after the metal components were found to be prone to fretting and corrosion at the modular neck junction. According to the company’s recall notice, recipients of those implants could experience pain, swelling and adverse local tissue reactions. In November 2014, Stryker agreed to pay at least t $1.43 billion to settle thousands of legal claims involving the Rejuvenate and ABG II devices.