Stryker LFit V40 Femoral Head Hip Problems Result in Hazard Alert

Australian health officials are warning about the risk of problems with some Stryker LFIT V40 femoral heads used during hip replacements, which have been linked to a high failure rate, raising concerns about the safety of the device worldwide. 

Stryker LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 may be prone to failure and problems, which could cause individuals to experience loss of mobility, pain, inflammation, local tissue reactions, dislocation, joint instability, broken bones around the components and the need for hip revision surgery.

In a warning issued on September 27, the Australian Therapeutic Goods Administration indicated that the modular components used in Stryker hip replacements have higher than expected rates of taper lock failures; which indicates failures where the femoral head connects to the femoral neck.

Australian officials identified item numbers for seven models of the Stryker LFIT hip femoral heads, with head diameters ranging from 36 mm to 44 mm. A complete list of item numbers is listed in the Australian warning.

The foreign regulators urge those who have received a Stryker LFIT V40 femoral head to be aware of the issue and talk to their healthcare professionals if they have any questions. They should also contact their healthcare professional if they experience any unexpected pain, loss of mobility, inflammation, instability, or any other problems that appear to be associated with the implant.

Doctors should follow up with patients who have been implanted with the affected components, especially if they complain of the above symptoms, Australian regulators said. Additionally Stryker has sent a notice to orthopedic surgeons who have use the implant.

The warning notes that it is possible that the problems with the Stryker LFIT hip implant components could be suffering taper lock failures due to a possible inconsistency with the taper lock interface. The regulators indicate that the problem could cause loss of implant, noise, limited movement, metallic debris, bone fixation strength, and other problems.

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 issue a Stryker LFIT V40 femoral head hip recall.