Arthrex IBalance Knee Lawsuit Filed Over Device Failure

According to allegations raised in a recent product liability lawsuit, design defects with the Arthrex iBalance knee replacement system may cause the implant to fail prematurely, resulting in the need for revision surgery. 

The complaint (PDF) was filed by Mandy Vanbibber in the U.S. District Court for the Southern District of Ohio on October 3, indicating that the Arthrex iBalance knee is unreasonably dangerous and harmful when used for it’s intended purpose.

Vanbibber indicates that she underwent bilateral total knee replacement in December 2014, with both knees replaced using Arthrex iBalance components. However, while her left knee worked fine, the right knee quickly began to experience problems, such as swelling, pain and instability.

Bone scans and x-rays indicated that the components had loosened and failed, resulting in hyperextension and medial lateral instability.

As a result of the knee replacement complications, Vanbibber required revision surgery in July 2016, and her surgeon deduced that the implant had undergone a complete tibial failure. He was able to remove the component simply by pulling on it.

“The iBalance knee implant was defectively designed and/or manufactured in that the iBalance knee implant failed to withstand normal and reasonable use by Plaintiff Mandy VanBibber, and otherwise failed to perform adequately and safely when used in an intended and reasonably foreseeable manner, so as to proximately cause injuries to the Plaintiff,” the lawsuit states. “The defects existed at the time the iBalance knee implant left the control of the Defendants and was introduced into the stream of commerce by Defendants Arthrex, Inc.”

The lawsuit claims that the risk of Arthrex iBalance knee failures outweigh its benefits.

Vanbibber’s complaint is one of a growing number of knee replacement lawsuits filed in recent months over problems associated with several different types of systems 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.

Vanbibber presents claims for negligence, defective design, formulation and manufacture, inadequate warning, breach of warranty, and her husband has filed a loss of consortium complaint as well.