Stryker issued hazard alert for LFIT Anatomic CoCr V40 hips in conjunction with the Therapeutic Goods Administration (TGA), Australia’s equivalent of the U.S. FDA. At the time of this writing, no such action has been taken by the FDA.
Stryker issued hazard alert for LFIT Anatomic CoCr V40 hips in conjunction with the Therapeutic Goods Administration (TGA), Australia’s equivalent of the U.S. FDA. At the time of this writing, no such action has been taken by the FDA.
The product, manufactured by Stryker Orthopaedics, is actually the femoral head, a part used in total hip replacements. The heads are surgically attached to the top of the femur (the longest bone in the leg) and fit into an acetabular shell, which then fits into the patients’ hip sockets. The hazard alert was issued when Stryker became aware that some of the LFIT Anatomic CoCr V40 femoral heads were more likely to have taper lock failures. The taper lock connects the heads to the femoral neck. The neck is the section connecting the head to the femur.
If the taper lock fails, patients could find themselves, literally, in a world of hurt. The possible results of taper lock failure include:
- loss of mobility
- pain
- inflammation
- adverse local tissue reaction
- dislocation
- joint instability
- broken bones around the components
- leg length discrepancy
- need for revision surgery
Currently, Stryker has determined that there are four products with this issue, but included three others that are similar in design just to be safe. The item numbers, head diameters and offsets are listed below:
Patients
If you have a LFIT Anatomic CoCr V40 femoral head as a component of your hip replacement, you need to be aware of the potential problems. It is advisable that you contact your doctor, specifically the implanting surgeon, if you have any of the above-listed symptoms.
Surgeons
If you are an orthopedic surgeon who has used the LFIT Anatomic CoCr V40 femoral head, you should have received information from Stryker on this problem. Stryker advises that the risk of taper lock failure is possible related to an inconsistency in the taper lock interface.
Continue to follow up with any patients in whom you’ve implanted these devices. Specifics to watch for include:
- disassociation of the femoral head from the hip stem
- fractured hip stem trunnion
- increased metallic debris
- insufficient range of movement
- insufficient soft tissue tension
- noise
- loss of implant
- bone fixation strength
- increased wear debris (polymetric)
- implant construct with a shortened neck length.
Sources:
LFIT Anatomic CoCr V40 Femoral Heads (Used In Hip Replacements)
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