In December 2015, the Arthrex iBalance TKA Tibial Tray was voluntarily recalled because the tibial tray was found to have a smooth texture that could interfere with proper bonding. Previous tibial trays had a rough texture. The smooth-textured tibial tray was recalled to avoid Arthrex iBalance knee replacement problems that could have resulted from incompatibility with other components.

After Arthrex issued the urgent medical device voluntary recall letters, the FDA issued its own Class 2 medical device recall announcement. The Class 2 recall is reserved for medical devices that can cause temporary or medically reversible adverse health consequences. In March 2016, the FDA announced the Class 2 recall that included more than 2,300 tibial trays.

Among the iBalance knee replacement problems, the tibial tray may be at risk for failure to properly bond. When the tibial tray doesn’t set correctly, the components don’t hold up to the stress of daily movement. Surgeons have reported being able to remove iBalance knee parts by simply pulling them by hand, due to the failure of the knee replacement to bond.

In one situation, a woman who underwent revision surgery had the tibial plate fall out when the surgeon gave it a gentle tug. She had reported uncontrollable pain, instability, and hyperextension of that knee since she had received the Arthrex iBalance knee in 2014. When she had the revision surgery in 2016, her surgeon was surprised to find the parts to be so loose they virtually fell out on their own.

iBalance Knee Replacement Problems Spark Lawsuits

The FDA had fast-tracked approval of the Arthrex iBalance knee replacement system in 2013, and Arthrex marketed the iBalance TKA as a superior option over traditional total knee replacement surgery. Marketing materials pushed the unique design and boasted of a reduced need for subsequent surgeries to remove metal plates and screws.

Instead, an abundance of iBalance knee replacement problems led to the Arthrex iBalance recall. More patients than anticipated have needed revision early surgeries.

Among the serious iBalance knee replacement problems are:

• Severe pain
• Inflammation
• Reduced mobility
• Infection
• Bone damage
• Nerve damage
• Disassociation of the insert
• Loosening
• Hyperextension
• Knee instability
• Total knee replacement failure

Patients suffering from iBalance knee replacement problems could endure severe and permanent injuries even after revision surgery. Lost wages, lost earning capacity and unanticipated expenses related to medical, hospital, rehabilitative and medicinal needs can adversely affect the patient’s lifestyle for a lifetime.

Affected patients claim the iBalance knee replacement problems could have been avoided entirely if Arthrex would have overseen adequate testing and quality inspections prior to placing the iBalance system on the market. Some patients who trusted the knee implant systems they received were state-of-the-art devices that would improve their mobility and their lives feel betrayed by the iBalance knee replacement problems that have left them with no choice but to undergo revision surgery.

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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