Howmedica Osteonics Corp. and its subsidiary, Stryker Orthopedics, face a lawsuit accusing the companies of being responsible for damages resulting from the Accolade Hip System, which includes the Accolade TMZF and LFIT V40 Cobalt Chromium femoral head components.

The intended function of these components is for use within a prosthetic hip replacement system.

Plaintiffs Richard F. and his wife, Enriqueta F. filed the Stryker Accolade hip failure lawsuit in the U.S. District Court for the District of Massachusetts.

Richard was implanted with the Accolade TMZF Plus and LFIT V40 femoral head on March 20, 2008 at Miriam Hospital in Providence, Rhode Island.

However, in early 2017 he began to suffer and experience significant pain where the hip replacement system was implanted. And upon a blood test, soon after, the testing revealed cobalt in the blood which then resulted in revision surgery of the hip replacement system in April 2017.

The Accolade TMZF, designed to be used with any surface material, is composed of zinc, iron, titanium, and molybdenum. It is thought to be highly versatile and is inserted into the femoral joint during prosthetic total hip replacements.

According to the Stryker Accolade hip failure lawsuit, the Accolade TMZF Hip Stem was developed, “to maximize a patient’s hip range of motion, increase stability, and resist dislocation.” And moreover, the surface materials of which the Accolade TMZF is composed of was designed to be used with the V40 Femoral head, that is composed of chromium alloy and cobalt.

According to the Stryker Accolade hip failure lawsuit, Stryker had claimed that there was compatibility between these materials and laboratory testing had proved that compatibility, especially without concern for corrosion and fretting. Despite these claims, however, reports have shown that the material combination does cause corrosion, the Stryker Accolade hip failure lawsuit alleges.

The attachment location of the Accolade TMZF and LFIT V40 has been allegedly found to cause dissemination, local inflammation, and corrosion. When corrosion occurs, the metal debris from the hip replacement system becomes circulated in the blood which can cause metallosis, or metal poisoning. Moreover, adverse effects of inflammation that occurs because of the dissemination of the metals can also lead to the growth of pseudotumors.

Revision surgery brought about due to the adverse effects and dissemination of the metals may be especially traumatic specifically due to the removal of the old hip implant and the hammered insertion of the new stem into the femur.

During the marketing and sale of the Accolade Hip System, “Stryker represented and warranted that its proprietary materials alleviate this problem,” the Stryker Accolade hip failure lawsuit contends.

In 2012, Stryker had issued a recall for its ABG II Modular Hip systems and its Rejuvenate Hip System.

According to the Stryker Accolade hip failure lawsuit, the two systems are comprised of the same titanium metal used in the TMZF. Additionally, the neck of the hip systems were also comprised of cobalt chromium.

The systems were recalled, the lawsuit explains, after reports surfaced, “indicating device failure due to fretting and corrosion at the taper junction where these dissimilar metals are joined.”

Styker, in 2016, also initiated an involuntary recall on the LFIT Anatomic CoCr V40 Femoral Head stating that it, “received higher than expected complaints of taper lock failure.”

The recall had announced that it was because the complaints had indicated hazards including but not limited to: dissociation of femoral head from hip stem, excessive metallic debris, and insufficient soft tissue tension.

The Stryker Accolade Hip Failure Lawsuit is Case No. 1:17-cv-10815-IT, in the U.S. District Court for the District of Massachusetts.