SANTA FE, New Mexico. — A New Mexico court recently awarded over $2 million to a plaintiff who claimed Zimmer’s M/L Taper Hip Prosthesis with Kinectiv Technology was defective.
After the case was heard as a bench trial in December, the court findings in March awarded the $2 million to the plaintiff on his strict products liability, or unreasonably dangerous design, claim against Zimmer, the medical device company now known as Zimmer Biomet.
The plaintiff, Michael Brian McDonald, developed metallosis around his M/L Taper Hip Prothesis and had to undergo two revision surgeries.
McDonald’s hip implant had a cobalt-chromium head and a stem/neck component made of titanium alloy. The metal-on-metal feature of the implant is what led to his metallosis.
Metallosis is a medical condition involving the deposition and build-up of metal debris in the soft tissues of the body. Metallosis causes necrosis, pain around the implant site, and pseudotumors. The implant can also loosen because the tissue intended to hold it in place becomes damaged and weak.
Following the original implant surgery in June 2010, McDonald was experiencing hip pain, groin pain, and loss of flexibility. Tests also revealed that his blood cobalt and chromium serum levels were elevated, with the cobalt level being particularly high.
As a result, just sixteen months after the initial surgery, McDonald had the first revision surgery to remove the M/L Taper Hip Prostheses and install a new Kinectiv modular neck and a new ceramic head. One month after that, McDonald had a second revision surgery.
Other than the stem base, all components of his implant were replaced.
The joint formed by the cobalt chromium femoral head and the titanium trunnion created friction between the two metals and caused corrosion, which led to the metallosis and the failure of the implant.
The complications with the implant caused some of the tissue around the site to die, and because not all of this necrotic tissue could be surgically removed, McDonald is permanently at risk for infection.
McDonald will have to be on a permanent course of antibiotics because of this constant risk.
It is also probable that a third revision surgery will be necessary, one that is more complicated than the previous two.
Based on McDonald’s medical complications, the court found that the MLTK with a metal cobalt chromium head was a defective product, and awarded the settlement to McDonald on the grounds of strict products liability (failure to warn), negligence, breach of express warranty, and breach of implied merchantability claims.
The court stated that the defectiveness of the device is in the interaction of the two metal components.
“The defective nature of the MLTK system is not that the components in isolation are defective, it is what happens when you put the components together,” the court wrote, according to Harris Martin Publishing. “Testing the function of a device requires testing with all components. It is not enough to test individual components of a system in isolation when it is known that there is an interaction between components of the system and performance of that system.”
Although the FDA does not require premarket testing of hip implant devices, manufacturers are obligated to design and sell safe products to the public. Additionally, they are responsible for warning patients of any risks or dangers associated with their devices.
The court concluded that because of the known link between metal-on-metal implants and complications like metallosis, Zimmer should have tested the device more thoroughly, as the dual-modular design with two metal-to-metal junctions was a new configuration.
The court awarded McDonald the $2 million for his lost enjoyment of life, past and future pain and suffering, lost earnings, past and future medical expenses, lost household services, and out-of-pocket expenses.
When a patient suffers significant complications or injuries due to a defective Zimmer hip device, it may warrant legal action.