An Arthrex knee recall initiated in December 2015 may affect knee replacement patients who received a defective tibial tray.

The Arthrex iBalance Total Knee Arthroplasty (TKA) System was designed to help those suffering from multi-compartmental knee cartilage degeneration, a result of either osteoarthritis or post-traumatic arthrosis. The Arthrex iBalance TKA Tibial Tray is a component of that system. It was the subject of an Arthrex knee recall in December 2015 after Arthex determined the smooth outer surface of the metal could lead to problems. Previous tibial trays had been made with a rough texture.

In December 2013, the Arthrex iBalance TKA System was approved by the FDA’s fast-track program. The system was advertised as “a novel and innovative instrument platform that facilitates an accurate, efficient and reproducible surgical technique.”

The FDA allows certain products to become approved without enduring the clinical trials that new products must undergo. If the medical device manufacturer demonstrates that their new device is substantially the same as another approved medical apparatus already on the market, the FDA fast-track approval process can apply.

Arthrex Knee Recall Issued

Doctors and medical facilities received Urgent Medical Device Recall notices from Arthrex in spring 2016. Any unused tibial trays were to be returned to the company, said the Arthrex knee recall, which affected more than 2,300 tibial trays that had already been distributed.

Shortly after Arthrex announced its recall, the FDA announced the Class 2 medical device was going to be removed from the market.

When the Arthrex iBalance TKA System was originally marketed, the company insisted the knee implant was better than any of its competitors. Arthex promised patients would need fewer surgeries with the iBalance system than they would with other implants.

Unfortunately, that did not appear to be true for many patients who ended up needing revision surgery. The Arthrex knee recall indicated affected patients could experience these complications:

• Severe pain
• Inflammation
• Mobility problems
• Infection
• Bone damage
• Nerve damage
• Deep vein thrombosis
• Muscle damage
• Loss of or lack of bonding of the knee implant to the bone
• Tibial loosening
• Disassociation of the insert
• Change in position of the components
• Patella-Femoral Tracking-Lateral Release (kneecap moves out of place)
• Knee replacement failure

A variety of serious side effects can cause a patient to need revision knee surgery. The knee is a delicate area, which means a subsequent surgery is particularly hard on the patient. Anyone who endures a second round of knee implant surgery is at a higher risk of infection, blood clots, bone loss, pain and swelling. Fragile nerves, tissue and blood vessels can suffer damage. As a result of significant bone loss, a second surgery can lead to one leg becoming shorter than the other.

Patients who undergo more than one knee replacement surgery on a knee will experience a higher risk of adverse side effects. Prior to the Arthrex knee recall, the company promoted the iBalance TKA System as a superior alternative to other knee replacement implant systems because the iBalance system did not require additional surgeries to remove hardware.

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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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