A plaintiff, Anna D., has filed an Accolade hip implant lawsuit in Tennessee federal court against Howmedica Osteonics Corp. and Stryker Orthopaedics, alleging serious adverse effects and complications regarding her Stryker Accolade hip implant.

The Accolade Hip Stem and the LFIT V40 Femoral Head are both sold and manufactured by the defendants, according to the Accolade hip implant lawsuit.

Plaintiff Anna D., a resident of Davidson County, Tenn., was implanted in both hips with the medical device in April 2007 at Thomas Midtown Hospital in Nashville, Tenn.

However, soon after their implantation, she claims, she began feeling serious discomfort. Additionally, a diagnostic workup showed loosening of the medical device, infection, and malposition, according to her Accolade hip implant lawsuit.

The Accolade hip implant lawsuit maintains the defendants have fraudulently concealed important information regarding the medical device and failed to disclose that information to the plaintiff and medical community.

According to the Accolade hip implant lawsuit, the defendants concealed the “true risks of harm associated with its V40/Accolade Stem combinations and fraudulently advised the medical community that instances of corrosion were not non-existent and/or extremely rare.”

The defendants face counts of negligence and breach of warranty.

According to the Accolade hip implant lawsuit, she is seeking punitive damages in the amount of $5,000,000 and requests a trial by jury.

Accolade Hip Implant Lawsuit Medical Device Facts

The Accolade TMZF Hip Stem and LFIT Anatomic V40 Femoral Head are parts that work together in a total hip replacement system.

In March 2000, the defendants received U.S. Food and Drug Administration (FDA) clearance to sell the Accolade stem and the LFIT Anatomic V40 Cobalt Chromium Femoral Head, in April 2001.

This clearance granted by the FDA was obtained through its 510(k) process. This method of clearance allows manufacturers to clear a product “if the manufacturer establishes that the new device is substantially equivalent to a predicate device; one that is already on the market.”

According to the Accolade hip implant lawsuit, therefore, substantial clinical studies were not required as part of the 510(k) process.

The stem, particularly indicated for patients requiring a total hip arthroplasty or replacement, is a single piece that is meant to be implanted into a patient’s femur. It is comprised of titanium alloy, containing titanium, molybdenum, zinc and iron.

However, the LFIT Anatomic V40 Femoral Head is also comprised of either Vitallium alloy (CoCrMo) and zirconia ceramic.

According to the Accolade hip implant lawsuit, there are instances when patients, including Anna, who have been implanted with the Accolade Stem/LFIT V40 head combinations suffer “catastrophic failure.” This includes fracturing incidences.

The Accolade hip implant lawsuit maintains, “it was reported that there was extensive corrosion in the V40 head and Accolade stem that was so significant the stem actually fractured at the stem/head juncture.”

Additionally, reports maintain that patients may also suffer from metallic debris that may cause significant adverse effects and complications including damage surrounding the soft tissues around the patient’s hips.

The Accolade Hip Implant Lawsuit is Case No. 3:17-cv-01182, in the U.S. District Court for the Middle District of Tennessee.