An Arthrex tibial tray recall was issued in December 2015 after the manufacturer found the outer surface of the metal was smooth, rather than displaying the rough texture of previous models.

The Arthrex iBalance TKA Tibial Tray is a component of the Arthrex iBalance Total Knee Arthroplasty (TKA) System.

Designed to treat multi-compartmental knee cartilage degeneration caused by osteoarthritis or post-traumatic arthrosis, the Arthex system claimed superiority over competitors. Patients were sold on the idea they would experience fewer revision surgeries to remove metal plates and screws.

Approved through the FDA’s fast-track program in December 2013, the Arthrex iBalance System was marketed as “a novel and innovative instrument platform that facilitates an accurate, efficient and reproducible surgical technique.”

The FDA’s fast-track process is controversial because it allows a medical device to be approved without the testing requirements that “new” products must submit if the manufacturer can prove the device is substantially equivalent to another approved device that is currently on the market.

Arthrex sent Urgent Medical Device Voluntary Recall letters to doctors and hospitals the spring of 2016. Nearly 2,380 trays are affected by the Arthrex tibial tray recall. Medical providers were instructed to return any non-implanted tibial trays to Arthrex.

After Arthrex issued the voluntary Arthrex tibial tray recall, the FDA announced the medical device was to be removed from the market.

Knee Implant Complications Force Arthrex Tibial Tray Recall

The Arthrex tibial tray recall affects patients who received the knee implant system and could suffer any of the following 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

Any severe side effects can result in the need for revision surgery. Going through a second knee surgery leaves a patient at higher risk for pain and swelling, infection, blood clots, bone loss, fractures and nerve, tissue or blood vessel damage. Repeated surgery can also lead to a discrepancy in the length of the patient’s legs.

According to the company website, Arthrex recognized the poor conditions that patients endure after having more than one knee replacement surgery. The iBalance Total Knee Arthroplasty (TKA) System was marketed as an alternative to traditional knee replacement surgery to ensure patients never needed a subsequent surgery.

Arthrex’s corporate headquarters are located in Naples, Fla. The company designs and manufactures joint replacement systems for shoulders, knees, elbows, hands, wrists, feet, ankles and hips.

If you or someone you love has undergone knee replacement surgery and is suffering from side effects from parts indicated in the Arthrex tibial tray recall, you could benefit from speaking with a lawyer regarding your legal options.

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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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