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Stryker Corp. is warning orthopedic surgeons that it has received a higher-then-expected number of reports involving hip failures associated with implants containing a specific femoral head manufactured prior to 2011, raising concerns about thousands of artificial hip implanted in recent years.
In an urgent medical device product field action notification (PDF) sent to health care professionals worldwide on August 29, the orthopedic device manufacturer warns of “potential hazards” associated with its LFIT Anatomic CoCr V40 Femoral Heads.
At issue are problems where the femoral head connects to the femoral neck, known as a taper lock failure. This can lead to a total hip implant failure, causing extreme pain, problems walking, and requiring revision surgery.
“Stryker has received higher than expected complaints of taper lock failure for specific lots of the following certain sizes of LFIT Anatomic CoCr V40TM Femoral Heads manufactured prior to 2011,” the letter states, providing a listing of catalog numbers, head diameters and offsets for affected components.
While the action has not been specifically labeled a Stryker hip recall, such a letter may end up classified that way by the FDA, as healthcare providers are being told to check their inventory and “quarantine all subject devices pending return to Stryker.” In addition, the letter specifies contact procedures if doctors “have any question related to this recall….”
For individuals who already received a Stryker hip replacement with the LFIT v40 femoral head, doctors are being urged to be on the look out for problems where the femoral head may disassociated with the hip stem, fracture, release excessive metal debris or cause symptoms such as:
- Pain, discomfort or annoyance
- Loss of mobility
- Adverse local tissue reaction
- Joint instability
- Periprosthetic fracture
- Leg length discrepancy
- Other problems requiring hip revision surgery
According to the letter, doctors have been asked to inform the manufacturer of any problems with Stryker LFit v40 hip implants, and to comply with regulations regarding notication of adverse events to regulatory authorities. However, it is unclear whether consumers who received the femoral heads will be notified directly that they may have a recalled hip replacement component.
Late last month, the Australian Therapeutic goods Administration reiterated the warning, and urged doctors to follow up with patients who had been implanted with the affected component.
In 2014, a number of lawsuits were filed in U.S. courts indicating that users had experienced Stryker LFIT V40 femoral head problems, alleging that the components were defectively designed and manufactured.
It is unknown at this time whether U.S. regulators will issue similar warnings, or potential require the manufacturer to formally issue a Stryker LFIT V40 femoral head hip recall.