A consumer has filed a lawsuit against Howmedica, alleging that the Stryker hip implant system is defective and can cause premature device failure.

New York resident Richard G., and his wife Gale G., recently filed a lawsuit against Howmedica Osteonics Corp., alleging that the Stryker hip implant system that Richard was implanted with was defective. The alleged defect caused him to need revision surgery less than a year after his original hip replacement surgery.

Richard alleges he had the Stryker hip implant system implanted in June 2015 during a routine hip replacement surgery. Less than a year later, in February 2016, Richard allegedly had the Stryker hip implant system removed due to unexpected side effects.

In his Stryker lawsuit, Richard claims that the system was defective, and the defects led to premature failure.

Stryker Hip Implant System

In April 2001, the Stryker hip implant system was approved by the U.S. Food and Drug Administration, allegedly through the 510(k) review process. The 510(k) process allows new medical devices onto the market by proving them sufficiently similar to an already approved device–meaning “it does not have to be tested in a single human being before placed on the market,” according to the couple’s lawsuit.

The Stryker hp implant system is composed of a femoral head and femoral stem which fit together through a “taper junction.” Richard claims, however, that this union’s poor design and the system’s material choices can lead to micro-fretting.

The fretting of components against each other can reportedly result in the release of metal debris. In extreme circumstances, the fretting can allegedly result in the femoral head falling off the femoral stem, referred to as catastrophic dissociation.

When micro-fretting releases metallic debris, it can allegedly cause serious side effects in patients. Consumers with the Stryker hip implant system have reported experiencing pain, limited range of motion, inflammation, disability, destruction of tissue, fluid collection, and pseudotumor development. These complications have led many consumers to undergo revision surgery, unable to live with the debilitating side effects of the Stryker hip implant system.

Hip Device Recall

In August 2016, following numerous consumer reports, Howmedica recalled their Stryker hip implant system. The recall cited dislocation of the femoral head from the hip stem, fractured hip stem trunnions, excessive metallic debris, and excessive wear debris as reasons for the recall.

Although Howmedica recalled the defective devices, Richard argues that their recall was vague, ambiguous, and did not advise consumers on how to proceed. Howmedica allegedly recommended that consumer use “continue to be followed for the normal protocol established by his, her surgeon.”

Richard claims that this is a misleading recommendation. A better recommendation would allegedly be to follow the guidance of the American Association of Hip and Knee Surgeons. This association recommends that consumers undergo MRI testing to determine if fretting and adverse tissue reactions have occurred.

Richard and Gale accuse Howmedica of negligence, negligence per se, strict products liability – defective design, strict products liability – manufacturing defect, strict products liability – failure to warn, breach of warranties, negligent misrepresentation, loss of consortium, unjust enrichment, and violation of state consumer protection laws.

Their Stryker hip lawsuit seeks compensatory damages, statutory damages, restitution, disgorgement, court costs, and attorneys’ fees.

The Stryker Hip Implant System Lawsuit is Case No. 1:18-cv-11335-IT and is part of the Stryker MDL, In re: Stryker LFIT V40 Femoral Head Products Liability Litigation, Case No. 1:17-md-02768-IT, in the United States Court for the District of Massachusetts.