In a total knee arthroplaasty (TKA), a surgical technique is performed that essentially removes damaged bone tissue existing on the ends of the femur and tibia—upper and lower leg bone, respectively—and replaces it with metal and polypropylene prosthetic components that allow for smoother articulation of the bones at the knee joint.

This surgery is used in cases of severe arthritis or traumatic injury. While there are many successful knee prosthesis available, several of them have mixed post-surgical performance reviews such as the iBalance TKA system.

The Arthrex Co. applied for U.S. Food and Drug Administration (FDA) approval of the iBalance TKA system through the 510(k) application process—a shortcut which has sometimes been referred to as a loophole.

The 510(k) process allows for a medical device to bypass several safety studies and enter the market by piggybacking onto a similar device that has already been approved. The process by which this connection is established is called proving “substantial equivalence.”

According to records, the FDA approved the iBalance TKA system in December 2013. Three years later, the Arthrex Co. issued a voluntary recall of the iBalance TKA system component known as the tibial tray. The recall, lasting from February until December 2016, affected 2,378 units in circulation.

The reason for the action was because of variances in texture on the outer surface of the tibial tray. These units were smooth and different from other trays with a textured or roughened surface.

Allegedly, there have been post-surgical problems show up in patients that have opted for implantation of the Arthrex iBalance TKA system. It is not known how variances in surface may have contributed to these complications, but it may be just one factor.

The side effects of this prosthetic have been reported as loosening, disassociation of the insert, change in component placement, muscle and bone damage, severe swelling and chronic pain.

For those with post-surgical pain and inflammation beyond the time frame of a normal healing process, the difficulties have been known to continue to the point of needing a total knee revision (TKR) surgery in which the prosthetic unit is removed and replaced with another alternative.

TKR surgery has been known to subject patients to serious risks such as deep vein thrombosis (DVT) and pulmonary embolism (PE). Both DVT and PE involve blood clots which can travel in the circulatory system after during and after such an invasive surgery and cause respiratory arrest, cardiac arrest, or even stroke.

Other adverse conditions related to TKR include bone tissue loss, problems with getting a new prosthetic to adhere to remaining bone surfaces in joint, leg length discrepancies, and possible infections. All these issues combine to create a picture of potential life-long issues with ambulation and a loss of enjoyment of life.

Did you or a loved one have to endure chronic pain and other side effects after having an Arthrex iBalance TKA system implanted? You may be entitled to legal compensation for your suffering.

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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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