The TGA Website Reports:
Consumers and health professionals are advised that Stryker Orthopaedics, in consultation with the TGA, has issued a hazard alert for a specific range of LFIT Anatomic CoCr V40 femoral heads.
LFIT Anatomic CoCr V40 femoral heads are modular components used in total hip replacement procedures.
It has been identified that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have a higher than expected incidence of taper lock failures. The taper lock is the part of the implant that connects the femoral head to the femoral neck.
If this occurs, the patient could experience:
This issue has been identified in four products, while three other products with similar specifications have also been included in the hazard alert as an additional precaution.
- loss of mobility
- adverse local tissue reaction
- joint instability
- broken bones around the components
- leg length discrepancy
- need for revision surgery
The affected products are:
Item number Head diameter Offset
6260-9-236 36mm 5
6260-9-240 40 mm 4
6260-9-244 44 mm 4
6260-9-340 40 mm 8
6260-9-344 44 mm 8
6260-9-440 40 mm 12
6260-9-444 44 mm 12