A former recipient of a hip prosthetic component made by Howmedica Osteonics Corp. joined the multidistrict litigation known as Stryker LFIT V40 MDL.

Plaintiff Franklin F. of Ohio is claiming physical injury and monetary loss secondary to the implantation of the LFIT V40 CoCr Femoral Head and Accolade II Femoral Stem. The hip replacement surgery took place at St. Francis Hospital in Poughkeepskie, N.Y. on April 22, 2013.

According to the short-form complaint, Franklin is not among the group of participants in the Stryker LFIT V40 MDL that have had the allegedly defective femoral head removed and replaced with an alternative device.

As several litigants involved in the Stryker LFIT V40 MDL have indicated through their respective counsel, however, his blood had tested positive for elevated levels of cobalt and chromium—an objective marker for metallic debris fretting which has come to be associated with the prosthetic hip component.

Stryker LFIT V40 MDL Allegations

According to the long-form Stryker LFIT V40 MDL complaint, the Accolade and other femoral stems compatible with the LFIT V40 femoral head are made of a specialized alloy called TMZF for short. TMZF stands for titanium, molybdenum, zirconium, and iron (Fe).

When TMZF comes in contact with chromium and cobalt that is present in the V40 and other femoral heads, plaintiffs allege there is a reaction that contributes to metal fretting. This corrosive activity allegedly leads to shards of metal being deposited in nearby tissues surrounding the hip, the formation of pseudo-tumors, and the elevation of certain metals in the blood, also called metallosis.

The second generation of the Accolade femoral stem which is applicable in this lawsuit—the Accolade II—is made of an alloy consisting of titanium, aluminum, and vanadium. It was approved by the U.S. Food and Drug Administration in March 2011 through a short-cut process known as the 510(k) review. This review doesn’t require clinical safety trials, but rather a similar device already on the market to piggyback.

The Stryker LFIT V40 MDL lawsuit indicates that defendant, Howmedica Osteonics Corp., aggressively marketed and warranted the LFIT to be paired with the Accolade despite previous experience which demonstrated that dissimilar metals promoted fretting at the juncture of the femoral head and stem.

Stryker had previously recalled their Rejuvenate and ABG II femoral stems made of TMZF because of this response, as well as resolving hundreds of claims through a settlement.

The Recall

On Aug 29, 2016, several lots of LFIT V40 femoral heads were globally recalled by Howmedica Corp. due to failure of the taper lock junction between the head and stem. Among the symptoms or evidence listed of failure included excessive metal and wear debris, fractured hip stems, and dislocation of the two components.

Plaintiff Franklin F. claims in this most recent lawsuit that he couldn’t have known that his suffering was connected to a defective hip prosthetic component prior to this recall. Furthermore, he indicates that he also wouldn’t have had any idea of the elevated metals in his blood or their connection with the faulty femoral head had he not been advised and had interpretation from a medical professional.

The Stryker Lawsuit is Case No. 1:18-cv-12659 in U.S. District Court for the District of Massachusetts.