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A New Mexico judge has ordered Zimmer, Inc. to pay $2 million in damages to a man who experienced problems with a Zimmer Kinective hip implant caused him to suffer metal blood poisoning and metallosis, as the device shed metal debris into his body.
Michael Brian McDonald filed a lawsuit against Zimmer after he had to undergo two revision surgeries in 2011, indicating that that the metal-on-metal design of an M/L Taper Hip Prosethesis with Kinective Technology (MLTK) caused elevated levels of cobalt in his blood and damage to surrounding tissue.
The Zimmer MLTK modular hip was first implanted in June 2010, but McDonald had to undergo revision surgery in October 2011, after he was diagnosed as suffering from adverse reactions to metal debris being shed by the implant. High levels of cobalt were also detected in his blood.
At that time, the cobalt head was replaced with a ceramic head. However, remaining necrotic tissue caused by the first implant led to an infection that ultimately required the ceramic femoral head and Kinectiv neck to also be replaced. McDonald also had to go through irrigation and debridement of the infection.
His doctor noted that the risks were discussed at the time, but believed that the potential benefits of the design outweighed the risk of metal blood poisoning.
On March 31, Judge Nan G. Nash, of the Second Judicial District in Bernalillo County issued a findings of fact and conclusion of law (PDF) in favor or McDonald’s claim of strict product liability, awarding McDonald $2,027,424,91 in compensatory damages. He ruled against punitive damages, and denied claims of failure to warn, negligence, and breach of warranty claims.
The judge determined that despite the warning, the device was still defective and unreasonably designed.
“It is never appropriate to design a hip implant system that would create an unreasonable risk of injury to the health or safety of a patient,” the court determined. “If a device is throwing off or creating so much metal debris and corrosion that it causes metallosis, that is not an acceptable risk of harm.”
In recent years, a number of hip recalls and problems have been associated with metal-on-metal designs. In addition, some concerns have been raised about the development of tumors and a potential risk of cancer that may be associated with the design.
Allegations were raised in nearly 12,000 DePuy ASR hip lawsuits filed against Johnson & Johnson, after their metal-on-metal implant was recalled in August 2010. Following several bellwether trials, the manufacturer ultimately agreed to pay more than $2.4 billion to settle the DePuy ASR litigation.
More recently, a new wave of hip implant cases have begun to emerge, involving individuals who received certain large-diameter femoral heads as part of their artificial hip replacement. The cases stem from a recent Stryker LFit V40 recall issued due to a high rate of problems experienced by individuals who received the femoral head used in various different types of hip systems, including Stryker Accolade, Stryker Meridian, Stryker Citation and other implants.