The Arthrex tibial tray recall was conducted in May 2016, after it was discovered that the texture on the outer layer of the knee prostheses might not work with other components. The Arthrex tibial tray recall stated this smooth texture made these products incompatible with earlier models that had a rough texture, which can increase the risk of premature device failure.

According to the Arthrex tibial tray recall, the company had entered the market withdrawal of specific iBalance TKA tibial tray components after the smooth texture was discovered.

Arthrex had reportedly sent Urgent Medical Device Voluntary Recall letters to their distributors, medical facilities, and surgeons that often prescribe their knee replacement system.

The FDA stated the Arthrex tibial tray recall affected approximately 2,378 Arthrex iBalance tibial trays, with the agency warning physicians to be wary against recommending the prosthetic to the patient.

The Arthrex iBalance TKA Tibial Tray is a component of the Arthrex iBalance Total Knee Arthroplasty (TKA), and was created to treat multicompartmental knee cartilage degeneration that is often caused by osteoarthritis or post-traumatic arthrosis.

Overview of Knee Replacement Complications

Also known as total knee replacement, arthroplasty is a surgical procedure designed to help resurface damaged knees suffering from arthritis. Metal and plastic components are typically used as caps at the end of the bones that form the knee joint and kneecap, to help repair the damages.

Due to the severity of multicompartmental knee cartilage degeneration, total knee replacement surgery is only prescribed to patients suffering from severe arthritis in their knees. Approximately 4.4 million patients have undergone knee replacement surgery in the United States, with patients often having to undergo revision surgery after a couple of years for device maintenance.

Arthrex had reportedly marketed the total knee replacement system as “a novel and innovative instrument platform that facilitates an accurate, efficient and reproducible surgical technique.”

This essentially means that Arthrex had marketed the iBalance Total Knee Arthroplasty system as a more convenient alternative to other knee prostheses, and is supposed to reduce the need for revision surgeries that are conducted to remove metal plates and screws.

However, a number of patients have allegedly reported serious complications in conjunction with knee replacement surgery including:

• Severe pain
• Inflammation
• Infection
• Bone damage
• Muscle damage
• Lack of bonding of the knee implant to the bone
• Tibial loosening
• Disassociation of the insert
• Change in component position
• Patello-femoral tracking-lateral release

These complications have forced many patients to undergo revision surgery, which carries a higher risk of infection. In addition to causing problems in the knee joints, knee replacement complications may potentially induce life-threatening complications like deep vein thrombosis.

It is important to note that the Arthrex iBalance knee replacement system was approved through the FDA’s 510(k) policy, which allows products to quickly enter the market. As long as the product works at an equivalent level with a similar product already on the market, then it may be eligible.

The Arthrex tibial tray recall is just one of several market withdrawals being conducted throughout the country, with many patients opting to join class action lawsuits. Patients who suffered serious knee replacement complications from the Arthrex iBalance tibial tray, may be eligible to file legal action against the company.

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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