A consumer recently filed a lawsuit against Howmedica alleging that his hip implant failed prematurely and that his Stryker LFIT V40 failure caused him to need revision surgery.

Plaintiff Carlos D.L. recently filed a lawsuit against Howmedica Osteonics Corp. over claims that he had to undergo risky revision surgery after experiencing Stryker LFIT V40 failure.

Carlos alleges he was implanted with the Stryker LFIT V40 femoral head in January 2014 during his right hip replacement surgery.

After experiencing adverse side effects due to Stryker LFIT V40 failure, Carlos reportedly had revision surgery in January 2018 to remove and replace the implant.

The Stryker LFIT V40 femoral head is a hip implant designed to be use with the Stryker LFIT V40 femoral stem as a part of a hip replacement.

The device was approved for use by the U.S. Food and Drug Administration (FDA) in 2001 through the 501(k) process.

The 501(k) process is a less rigorous approval process which requires manufacturers to prove that their new device is reasonably similar enough to an existing, approved product.

If a device gains approval through this process, it is not required to go through any clinical testing before it is sold on the market.

Although this can streamline the approval process, Carlos argues that it allowed Howmedica to sell a device prone to Stryker LFIT V40 failure.

The design of the implant connects the femoral head with the femoral stem in a “taper junction” which uses dissimilar angles in order to fix the components.

Carlos argues that this junction is poorly designed, and can lead to micro-motions and fretting. This allegedly caused the corrosion of components, release of metallic debris, and eventual Stryker LFIT V40 failure.

In extreme situations, the fretting of the components can cause the femoral head to completely fall off the femoral stem. This phenomenon, described as catastrophic dissociation in medical literature, is a dramatic form of Stryker LFIT V40 failure.

According to Carlos’ lawsuit, the Stryker LFIT V40 tapers are “the only commercially available stem/head combinations to have suffered these catastrophic failures.”

In August 2016, Howmedica initiated a voluntary recall of certain lots of their femoral head products, citing Stryker LFIT V40 failure as the cause.

Although the company initiated the recall, Howmedica allegedly minimized the magnitude of the problem with their femoral heads and portrayed that Stryker LFIT V40 failure was unlikely in lots besides the ones involved in the recall.

Carlos accuses the defendants of negligence, design defect, manufacturing defect, failure to warn, breach of warranties, violation of state consumer protection laws, negligent misrepresentation, and unjust enrichment.

Carlos’ wife Irma also brings loss of services and loss of consortium claims.

The Stryker LFIT V40 failure lawsuit seeks compensatory damages, statutory damages, restitution, disgorgement, court costs, and attorneys’ fees.

The Stryker LFIT V40 Failure Lawsuit is Case No. 1:18-cv-11718-IT and is part of the Stryker LFIT V40 MDL, In re: Stryker LFIT V40 Femoral Head Products Liability Litigation, Case No. 1:17-md-02768-IT, in the U.S. District Court for the District of Massachusetts.