Plaintiff Neils F. has filed a hip implant lawsuit in Louisiana federal court alleging that he suffered adverse effects due to an implant of the Accolade TMZF hip stem.

The Accolade TMZF hip stem is manufactured by Howmedica Osteonics Corp. and Stryker Orthopaedics, both named defendants in the products liability litigation.

According to the Accolade TMZF hip stem lawsuit, Niels, a resident of Shreveport, La., was implanted with the device in April 2012 at Hunt Regional Medical Center in Greenville, Texas.

However, soon after, he began to experience severe discomfort in the area of the device. He later underwent revision surgery to help ease the discomfort and other adverse side effects and complications that he was experiencing.

Accolade TMZF Hip Stem Allegations

The total hip replacement system Neils received, manufactured by Howmedica Osteonics Corp. and Stryker Orthopaedics, is comprised of the Accolade TMZF Hip Stem and the LFIT Anatomic V40 Femoral Head.

This system, inserted into a patients hip to help increase range of motion and stability, was cleared for sale by the U.S. Food and Drug Administration in March 2000. The device went through a process of the FDA known as a 510(k) clearance process. They began to sell the device in April 2001.

The 510(k) clearance process granted by the FDA allows a quick method for clearance. The process allows manufacturers to quickly clear a product if the product is “substantially equivalent” to another product already being sold on the market.

In the 510(k) approval method, manufacturers of products do not have to conduct clinical studies and thoroughly prove the efficacy and safety of the product at hand.

The issue, according to the Accolade TMZF hip stem lawsuit, is that although the hip stem was designed to improve and increase mobility, flexibility, and range of motion, the hip stem is more prone to corrosion and mechanic wear and tear when inserted or implanted into a patient’s hip.

The stem, 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. However, complications and adverse effects have been reported, some of which require revision surgery to fix.

These complications are blamed on the metal-on-metal contact between the parts of the hip system. The LFIT Anatomic V40 Femoral Head is a metal component made of Vitallium alloy, containing chromium and molybdenum. The TMZF hip stem is comprised of titanium alloy, containing titanium, molybdenum, zinc and iron.

According to the Accolade TMZF hip stem lawsuit, when these products are implanted, they rub together, releasing metal particles into the patient’s soft tissue and bloodstream, causing a condition known as metallosis. The condition of metallosis involves the involves the build-up of metal debris in the body’s soft tissue which can cause damage and further accumulate around the hip joint causing further soft tissue growths, pain, swelling, and bone loss.

This metal debris may also begin to circulate in the patient’s bloodstream causing other serious complications and adverse effects.

In some instances, patients implanted with the Accolade Stem/LFIT V40 Head combinations may suffer catastrophic failure. Fracturing incidences may occur with the patient’s hip implant. This occurs when much corrosion has occurred within the area, completely disintegrating the metal compounds that the parts are composed of.

The Accolade TMZF Hip Stem Lawsuit is Case No. 5:17-cv-01075-SMH-MLH, in the U.S. District Court for the Western District of Louisiana.