Howmedica faces a new lawsuit from a patient alleging that Stryker LFIT defects caused her hip replacement to fail and necessitated revision surgery.

Plaintiff Verlene T. recently filed a lawsuit against Howmedica Osteonics Corp., alleging that Stryker LFIT defects caused her hip replacement system to fail which lead to revision surgery. Verlene says she was implanted with the LFIT V40 femoral head in November 2012 and had the device explanted in August 2016 during revision surgery.

The LFIT V40 femoral head is part of a metal-on-metal hip replacement system. The femoral head fits together with the associated femoral stem through a “press fit” trunnion. This angular mismatch between the two components is supposed to obtain a reliable fixation, but Verlene claims that this connection is one of many Stryker LFIT defects.

Allegedly due to “poor design and material choices,” micro motion and fretting can reportedly occur at the connection which releases metal wear debris into the body. In extreme cases, the wear and fretting can allegedly result in the femoral head falling completely off of the femoral stem.

According to the Stryker LFIT defects lawsuit, the V40 tapers are the only commercially available stem/head combos to experience this phenomenon, known as catastrophic dissociation.

In less dramatic situations, the wear of fretting and release of metal debris can lead to high levels of cobalt and chromium in the blood. This metal poisoning can cause an adverse local tissue reaction, tissue and bone death, formation of fluid collections and pseudotumors, and more. These complications caused by Stryker LFIT defects can lead to the need for revision surgery.

In August 2016, after receiving reports of revision surgery necessitated by Stryker LFIT defects, Howmedica recalled various lots of the Stryker LFIT V40 femoral heads. The company cited “higher than expected” incidences of taper lock failure and identified several potential complications.

Although the company recalled the femoral head, Verlene claims that the recall was insufficient and intentionally “minimized the gravity and magnitude of the problem.” Additionally, the company allegedly failed to advise medical professionals such as surgeons of how to care for and follow up on at-risk patients.

“Defendants knew that by providing ambiguous, and misleading ‘recommendation’ that patients would not be notified of the recall, would not return to their surgeons and would not receive any testing to diagnose problems that if promptly detected could mitigate ongoing tissue damage or prevent catastrophic failure like disassociation of the femoral head from the stem,” the Stryker LFIT defects lawsuit claims.

Verlene accused Howmedica of negligence, defective, design, manufacturing defect, failure to warn, breach of warranties, negligent misrepresentation, loss of consortium, unjust enrichment, and violation of consumer protection laws.

The Stryker LFIT defects lawsuit seeks compensatory damages, statutory damages, restitution, disgorgement, court costs and attorneys’ fees.

The Stryker LFIT Defects Lawsuit is Case No. 1:18-cv-11849-IT and is a part of the Stryker LFIT MDL, In re: Stryker LFIT V40 Femoral Head Products Liability Litigation, Case No. 1:17-md-02768-IT, in the United States District Court for the District of Massachusetts.