Stryker Accolade problems with the hip implant parts made by Howmedica have led to a lawsuit filed by patient Amy D.

Amy says she was implanted with the Accolade Hip Stem and the LFIT V40 Femoral Head in August 2014. Shortly after implantation, she says she began experiencing Stryker Accolade problems. Diagnostic tests indicated fluid had built up in and around the hip implant, a condition consistent with device failure.

Amy says she is still enduring the pain and suffering of Stryker Accolade problems and has not yet had the components removed.

She alleges Stryker “fraudulently concealed relevant facts from plaintiff (herself) and the medical community abou the true risks of harm associated with its V40/Accolade Stem combinations and fraudulently advised the medical community that instances of corrosion were non-existent and/or extremely rare.”

Stryker’s Accolade hip systems include several variations of neck, stem and head components that can vary in size and material. The interchangeable components were designed to ie surgeons more flexibility to custom-fit the implants to the patients.

The Accolade hip stem was cleared through the FDA’s fast-track process that allows a manufacturer to establish that a new device is substantially equivalent to a predecessor that is already on the market.

The Accolade stem is made using a proprietary titanium alloy that includes molybdenum, zinc and iron. Howmedica patented the design and claimed that the alloy was stronger and less rigid than other titanium alloys. The company also claimed that tests proved the stem was resistant to corrosion and fretting.

Stryker Accolade Problems Begin

The Journal of Bone and Joint Surgery published an investigative report in August 2016 that discussed five occurrences of Stryker Accolade problems that led to catastrophic failure when the Accolade stems fractured. Extensive corrosion in the V40 head and Accolade stem caused the stem to break at the stem and head juncture.

Many patients also suffered significant damage to surrounding soft tissues from metallic debris caused by the corrosion.

After that report came out, Stryker issued a recall, identifying certain hazards that included dislocation of the femoral head from the hip stem, fractured hip stem trunnions, excessive metallic debris, and excessive wear debris.

Although Stryker Accolade problems were identified, “the recall notice provides no information concerning the cause of the failures or steps surgeons can take to monitor patients.”

While a simple blood test can determine whether a person is experiencing device corrosion, the recall notice doesn’t address the possibility of corrosion at the head and neck juncture.  The blood test can detect the presence of abnormally elevated levels of cobalt, chromium, or titanium in the system.

“As a result, there are potentially several hundred thousand individuals with defective V40 heads whose hips are currently leaching toxic levels of cobalt and chromium into their bodies who are completely unaware that their hips are corroding,” says the lawsuit alleging Stryker Accolade problems.

Amy says the Stryker Accolade problems “are much larger than those referenced” in the recall notice and “are caused by the metallurgical formula used to manufacture” the stem and the configuration of the cobalt-and-chromium V40 head.

The Stryker Accolade Problems Lawsuit is Case No. 5:17-cv-01076-EEF-KLH in the U.S. District Court for the Western District of Louisiana.