Howmedica Osteonics Corp. faces a woman’s recent Stryker LFIT V40 failure lawsuit. She filed the suit due to severe adverse effects and complications she says she suffered following medical device implantation.

Plaintiff Mary Jane N. files the Stryker LFIT V40 failure lawsuit in Massachusetts federal court, joining a growing multidistrict litigation (MDL) against the company. Mary filed the lawsuit on March 30, 2018.

According to the Stryker LFIT V40 failure lawsuit, Mary Jane, an Arkansas resident, was implanted with the LFIT Anatomic CoCr V40 Femoral Head on her right hip on April 30, 2009 at Baptist Health Medical Center. She says she was also implanted with the Accolade TMZF, the device’s femoral stem, during the surgery.

However, due to complications suffered, the device was removed on Aug. 27, 2015. She says that it was only after having her blood drawn that she learned of the excessive levels of chromium and cobalt in her blood, allegedly stemming and attributable to a defective device.

The Stryker LFIT V40 failure lawsuit was filed on multiple counts, listed as negligence, negligence per se, defective design, manufacturing defect, failure to warn, breach of express warranty, breach of warranty as to merchantability, breach of implied warranty, Violation of Consumer Fraud and Deceptive Trade Practices Under State Law, negligent misrepresentation, unjust enrichment, and punitive damages.

Mary Jane demands a trial by jury.

Stryker LFIT V40 Failure

A number of lawsuits have been filed against Howmedica Osteonics Corp., a subsidiary of Stryker Orthopedics, alleging that their metal hip device is linked to an extensive number of hazards and problems including hip stem fractures, loss of bone fixation strength, insufficient range of motion, and dissociation of the femoral head from the stem.

The issue with metal-on-metal (MoM) hip implant devices, such as when a metal femoral head becomes attached to a metal femoral stem, is that the metal ball and socket rub against one another. This can cause the shedding of metal ions into the tissue surrounding the device as well as into the bloodstream, a severe adverse side effect.

In August 2016, Stryker announced and sent out an “Urgent Medical Device Recall Notification” letter to surgeons and doctors implanting patients with a Stryker V40 femoral head device manufactured prior to 2011.

According to the recall notice, Stryker “had received higher than expected complaints describing incidences of harm secondary to taper lock failure for specific lots of LFIT V40 heads.” The recall notice also advised and listed potential hazards of the device that included “dislocation of the femoral head from the hip stem,” fractured hip stem trunnions,” “excessive metallic debris” and “excessive wear debris.”

The U.S. Food and Drug Administration (FDA) stated their concerns that MoM devices have their own unique risks for patients on top of general hip implant risks. Measures advocated by the FDA for any patient experiencing adverse side effects include them having soft tissue imaging done, blood tests to check metal ion levels, and joint aspiration for the removal of tissue from around the joint.

The Stryker LFIT V40 Failure Lawsuit is Case No. 1:18-cv-10621-IT, in the U.S. District Court for the District of Massachusetts. The Stryker V40 MDL is In re: Stryker LFIT V40 Femoral Head Products Liability Litigation, MDL No. 17-md-2768-IT, in the U.S. District Court for the District of Massachusetts.