A husband and wife have filed a Stryker V40 femoral head lawsuit because the husband’s metal-on-metal hip implant failed.

Plaintiff Mark I. received a left hip implant consisting of the Stryker V40 femoral head and an Accolade TMZF stem in December 2011.

On Oct. 20, 2016, he underwent surgery to remove the Stryker V40 femoral head because of pain and problems allegedly caused by cobalt and chromium entering the surrounding tissues and his blood stream.

Mark’s Stryker V40 femoral head lawsuit joins a multidistrict litigation, or MDL, in the U.S. District Court for the District of Massachusetts.

According to the MDL, the connection between the V40 chrome and cobalt head and the femoral stem is poor due to an inferior design and material choices that allow the parts to fret and create metal debris.

The Stryker V40 femoral head lawsuit says, “In the most extreme circumstances, corrosion fueled by motion and accompanied by massive metal loss can result in the femoral head falling off the femoral stem, a phenomenon described in the medical literature as catastrophic dissociation.”

Metal debris can cause the localized tissue to react by building up fluid or even by the tissue dying. Sometimes pseudotumors develop, which cause additional pain, pressure and swelling.

Stryker V40 Femoral Head Lawsuit Alleges Negligence

The Stryker V40 femoral head is made of a cobalt and chromium alloy. The Accolade TMZF stem is made of a proprietary metal alloy consisting of titanium, molybdenum, zirconium and iron.

“Stryker’s proprietary TMZG titanium alloy causes a significant amount of toxic corrosion when it is implanted in contact with CoCr (cobalt/chrome), like the LFIT V40 femoral head,” says the Stryker V40 femoral head lawsuit.

Stryker faces allegations that the company knew or should have known that the stem made of the TMZF alloy would be prone to failure when paired with the chrome and cobalt head.

In 2012, Stryker recalled the ABG II and Rejuvenate femoral stems because corrosion occurred when a TMZF titanium stem was paired with a cobalt and chromium femoral neck. This recall shows that the company knew the differing metals were a problem.

The company also is accused of violating various federal Food, Drug, and Cosmetic Act (FDCA) regulations including, but not limited to:

• Failing to report adverse events to the FDA
• Failing to investigate and analyze hip implant failures in a timely manner
• Failing to warn of the risk of metal poisoning from the corrosion of the hip implant devices

The Stryker V40 femoral head lawsuit claims the company “negligently designed, manufactured, marketed, detailed, labeled and advertised, both to physicians and consumers, the LFIT CoCr V40 Femoral Head and its accompanying femoral stems.”

The Stryker V40 Femoral Head Lawsuit is Case No. 1:17-md-02768-IT and is part of the Stryker LFIT V40 MDL, In re: Stryker LFIT V40 Femoral Head Products Liability Litigation, MDL No. 17-md-2768-IT, in the U.S. District Court for the District of Massachusetts.