In February 2016, the Arthrex company initiated a voluntary Arthrex iBalance recall for components of its knee prosthetic unit after discovering significant textural discrepancies.

The voluntary Arthrex iBalance recall was started after finding that some of the device components were reported as having an outer metal surface that was smooth.

These reports stood in sharp contrast to previous models which had a rough exterior metal surface. The differences alerted the company that components made to work together might not articulate well.

The Arthrex iBalance recall ostensibly affected 2,378 units that were in distribution. Notice was sent to medical professionals, facilities, and distributors about the manufacturing discrepancies and request was made to pull all identified components from commerce that were not already implanted in patients.

A month later, in March 2016, the U.S. Food and Drug Administration (FDA) announced the voluntary recall as a Class 2 Arthrex iBalance recall.

Class 2 medical device recalls are reserved for devices that can cause harm but whose harm is not irreversible or life-threatening. The FDA action reiterated that use of the device should be stopped in all circumstances.

The Need for Early Knee Revision

The Arthrex iBalance knee prosthetic was created as a total knee arthroscopy choice for patients troubled with complete degeneration of cartilage in the joint.

It was hoped that the design would present no need for further revision surgery unlike other prosthetics which, at the very minimum, often require replacement of the prosthetic plastic meniscus after a few years of use.

Unfortunately, the manufacturing discrepancies and other undisclosed issues contributed to numerous recipients needing early knee revision surgery. This early revision surgery was usually to completely change out the prosthetic–not just a part.

An additional surgery like this comes with significant risks such as blood clots, bone tissue loss, and a heightened chance that a new prosthetic joint will not adhere or stabilize correctly.

Other knee replacements have led to problems that contributed to early revision surgery as well. Several varieties of metal-on-metal prosthetics have led to a condition called metallosis in which metal particles have shed into the joint area and caused horrendous pain and inflammation as well as unusually high levels of chromium and cobalt in the blood itself.

These metals in the blood have been found to contribute to certain types of cancer and heart disease if left undetected.

Other issues that have led to early revision surgery by patients that have undergone total knee arthroscopy are inadvertent fracture, loosening of the stem of the femoral head due to a failure to grow into the bone, and chronic pain from the knee’s inability to track and stabilize properly.

If you have been a recipient of a Arthrex knee prosthetic and have had to have early knee revision surgery due to problems, you may have a claim secondary to the Arthrex iBalance recall. A medical product liability lawyer can review your case.

Get a Free Knee Replacement Case Review

If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.

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