Recent recalls, both voluntary and mandatory, are clouding the reputation of Stryker LFIT femoral heads.

The femoral heads affected by these recalls are components in some of Stryker’s prosthetic hip implant systems, used in patients who undergo total hip replacement surgery.

The femoral head is the ball-shaped component that attaches to the femoral neck by means of a taper lock.

The whole assembly is implanted at the upper end of the femur, and the femoral head inserts into the hip bone, taking the place of the original, natural hip joint.

Recalling the Stryker LFIT Femoral Heads

So far, recent reports of problems with these Stryker LFIT femoral heads have led to two recalls by Canadian regulators.

The Canadian recalls began in September 2015, based on reports that Stryker’s LFIT V40 femoral heads could not be assembled with the corresponding V40 stem trunnion. The recall specifically sought femoral heads manufactured between July 7 and Aug. 15, 2014.

Then in August 2016, Health Canada issued another announcement based on a larger than expected number of reports of taper lock failure in certain Stryker LFIT femoral heads manufactured before 2011.

Over the next few months, Australian regulators issued warnings based on similar reports of failure associated with Stryker LFIT V40 femoral heads.

In September 2016, the Therapeutic Goods Administration issued a hazard alert based on a higher than expected number of reports of failure and injury associated with Stryker femoral heads.

The next November, the Medicines and Healthcare Products Regulatory Agency followed up with an Urgent Field Safety Notice, announcing a recall of Stryker LFIT V40 femoral heads manufactured between January 2002 and March 2011.

The agency said Stryker had received an inordinate number of reports of taper lock failure in these components.

Reported Defects and Complications

Taper lock failure can lead to serious complications. Patients could suffer from joint dislocation, instability, loss of mobility, inflammation, pain, or leg length discrepancy.

Complications like these may require revision surgery to remove and replace the Stryker implant.

In the U.S., the FDA has not yet issued a recall of the Stryker LFIT femoral heads. However, in August 2016, Stryker initiated a voluntary recall of those femoral heads on its own initiative.

Stryker says the femoral heads affected by the recall have either expired or already been implanted. In the company’s Aug. 29 announcement of the voluntary recall, it alerts hospitals and surgeons to be on the lookout for symptoms of complications in patients who have already been implanted with the recalled femoral heads.

In the components affected by some of these recalls, corrosion has been reported at the point where the femoral head joins the stem beneath it.

Like other metal-on-metal implants that have been the subject of many hip implant lawsuits, these components could release metal ions into the surrounding tissue.

An excess of metal in the tissue or bloodstream can lead to a toxic condition called metallosis. This increased metal toxicity can lead to death of the muscle and bone tissue surrounding the implant, causing pain and failure of proper implant function.