A couple has filed a lawsuit against Howmedica Osteonics Corp. after the husband suffered a Stryker LFIT V40 failure in his hip implant.

Plaintiff Dick D. received a right hip implant that included the LFIT Anatomic CoCr V40 femoral head in December 2010. He had the femoral head explanted in September 2017.

He received a left hip implant that included another LFIT Anatomic CoCr V40 femoral head in February 2015. He has not yet scheduled the removal of the left femoral head from the Stryker LFIT V40 failure.

Stryker LFIT V40 Failure Marked by Metal Poisoning

According to the master complaint for the Stryker LFIT V40 multidistrict litigation, “poor design and material choices lead to micro-motion, fretting, corrosion, and ultimately, failure of the device due to the generation of metal wear debris.”

In extreme cases, the corrosion can lead to catastrophic dissociation, which means the metal has worn away to the point that the femoral head falls off the femoral stem.

The metal-on-metal hip system results in tiny particles of metal fretting away, which can make their way into nearby tissue. The affected tissue can die or develop large pseudotumors.

As metal ions are released into the body, bone also can become brittle and die. Metal ions may enter the blood stream. A simple blood test can determine if metal poisoning (metallosis) is present.

The Stryker LFIT V40 failure lawsuit says the femoral heads were made in different sizes in order to be paired with a variety of femoral stems. Different tapers (a cone inside a cone) are used to match the LFIT V40 heads with different stems. The defective design of the V40’s tapers allow the head to move on the stem, which leads to corrosion and fretting.

Stryker LFIT V40 Recall

In August 2016, Howmedica issued a voluntary worldwide recall of certain lots of heads due to a “higher than expected” incidence of Stryker LFIT V40 failure. They pinpointed the taper lock as the main issue that caused dislocation of the femoral head from the hip stem, fractured hip stem trunnions, excessive metal debris and excessive wear debris.

The recall notice indicated the LFIT V40’s problems included needs for revision surgery, inflammation, adverse local tissue reaction, dislocation and “periprosthetic fracture,” which is a broken bone that occurs around the hip implant.

According to the Stryker LFIT V40 failure lawsuit, the notice “acknowledged that they had received reports of device failure due to heavy metal contamination.”

The recall notice “provides no guidance whatsoever to the surgeons since many of these failures occurred a number of years after the implantation and most surgeons don’t require follow-up of a patient beyond the first year or two following implant.”

The Stryker LFIT V40 failure lawsuit alleges that the ambiguity of the notice and the misleading recommendations to surgeons would minimize the number of patients who would be notified of the recall. As a result, they would not return to their surgeons and would not receive a test to diagnose issues that could be caught early, preventing catastrophic implant failure.

The Stryker LFIT V40 Failure Lawsuit is Case No. 1:17-md-02768-IT and is part of the Stryker LFIT V40 MDL, In re: Stryker LFIT V40 Femoral Head Products Liability Litigation, MDL No. 2768, in the U.S. District Court for the District of Massachusetts.