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According to allegations raised in a recently filed product liability lawsuit, problems with an Arthrex iBalance knee replacement caused an Arkansas woman to experience complications only a few months after the device implanted, resulting in the need for revision surgery.
The complaint (PDF) was filed by Angela Owen in the U.S. District Court for the Western District of Arkansas on February 25, indicating that Arthrex, Inc. manufactured and sold defective components, which were unreasonably dangerous and prone to fail.
Owen underwent total left knee replacement in November 2015, at which time an Arthrex iBalance knee system was implanted by her surgeon. However, following the procedure, she suffered severe pain, swelling and numbness around the knee and her surgeon removed the implant in April 2016.
During the surgery to remove the implant, the doctor noted that the tibial tray was extremely loose. The surgery occurred just a month after the FDA announced an Arthrex iBalance knee replacement recall, which impacted about 2,300 units in March 2016, because some of them had a smooth outer surface which should have been textured. Those textured surfaces were designed to help with the cement bonding process of the tibial tray.
It is unclear whether her implant involved in the lawsuit was one of those recalled knee replacements. However, Arthrex iBalance tibial tray problems have been reported separate of the recall. Owen’s lawsuit indicates that there is a problem with the design of the knee replacement system which results in a high early failure rate.
“The Arthrex iBalance, as manufactured and/or supplied by Defendant, was defective due to its high early failure rate. Defendant knew or should have known that the product created significant risks of serious bodily harm to consumers, as alleged herein, and it failed to adequately warn consumers and/or their health care professionals of such risks,” the lawsuit states. “The benefits of the Arthrex iBalance do not outweigh the risks inherent in the design and configuration of the Arthrex iBalance.”
Over the past year, a growing number of knee replacement lawsuits have been brought by individuals who experienced problems with Arthrex iBalance imlpants, as well as several different types of systems that have been widely used in recent years.
Similar tibial failures have also been cited in recent DePuy Attune Knee lawsuits, as well as complaints over the Exactech Optetrak Total Knee Replacement System. In both cases, plaintiffs say that problems with tibial loosening resulted in implant failures.