Knee replacement is one of the most common orthopedic surgeries done, with close to five million done each year in the U.S.

Total knee arthroscopy (TKA) is done to replace articulating parts at the joint that have severely deteriorated due to osteoarthritis or traumatic injury to the cushioning cartilage. The Arthrex iBalance total knee prosthetic was created for implantation in this type of situation.

On March 19, 2016, the U.S. Food and Drug Administration (FDA) announced a Class 2 medical device recall on one component of the Arthrex iBalance total knee prosthetic—the tibial tray.

Class 2 medical device recalls are issued when a product may cause temporary but possibly reversible adverse health problems. In the case of the Arthrex iBalance total knee tibial tray, the manufacturer issued a voluntary recall after discovering a smooth texture on the outer surface that made it not work with previous versions that had a rough texture.

The Arthrex iBalance total knee tibial tray Class 2 medical device recall affected 2,378 units in domestic circulation in 29 states, including the District of Columbia.

Urgent letters were sent in February prior to the follow-up action on the part of the FDA in March to distributors and medical and surgical facilities likely to implant the Arthrex iBalance total knee prosthetic.

Arthrex iBalance Total Knee Failure

The Arthrex iBalance total knee prosthetic, along with the DePuy Synthes Attune knee system and Exactech Optetrak knee system, have been connected to some problematic post-surgical adverse effects.

Some of these adverse effects can be considered joint prosthetic failure and have led to knee revision surgery. Some of these adverse effects include:

• Loosening or disassociation of implant
• Pain, swelling, chronic inflammation
• Fractures
• Infections
• Immobility or instability
• Moving kneecap

The Arthrex iBalance total knee prosthetic was designed to be implanted without the need for a second surgery, so it is ironic that reports of adverse events associated with the knee replacement unit would indicate that the opposite is true—more recipients need revision surgeries.

These revision surgeries often result in complete removal of the former prosthetic in favor of a different option.

Revision surgeries are expensive and cost the patient not only a great deal in hospital and medical bills, but also cost in terms of the necessary time one has to take off from work while experiencing problems beforehand and during the healing process.

Any surgery that requires that use of a general anesthetic, of course, presents a certain number of risks. A significant risk with a first or repeat knee replacement would be blood clots which, when they travel to the heart, lungs, or brain can cause cardiac or respiratory arrest and stroke.

There may also be difficulties with a second prosthetic in terms of bone tissue loss with repeat knee replacement. Bone tissue loss can make a second unit difficult to stabilize. Without stabilization, the patient can be rendered permanently disabled.

Filing a knee replacement lawsuit can help offset the financial losses associated with this unfortunate turn of events. If you have had problems with any of the above prosthetics, you could qualify for compensation.

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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