The Arthrex iBalance TKA (total knee arthroplasty) Tibial Tray was recalled from the market in December 2015, after a possible manufacturing defect was discovered.

The Arthrex iBalance TKA tibial tray is a component of the popular Arthrex knee replacement system, which is designed to help patients suffering from multi compartmental knee cartilage degeneration due to either osteoarthritis or post traumatic arthritis.

However, some units of the Arthrex iBalance TKA tibial tray were discovered to have a smooth outer surface that could make it incompatible with other implant components. It is important to note that earlier tibial trays had been made with a rough exterior.

The Arthrex iBalance TKA System was approved by the FDA 510(k) program in December 2013, which was through the agency’s fast track approval process for similar products.

Overview of Arthrex iBalance TKA Tibial Tray Problems

When the Arthrex iBalance TKA System was approved and released to the market, the device was marketed as “a novel and innovative instrument platform that facilitates an accurate, efficient and reproducible surgical technique.”

When the device was first released, Arthrex touted it to be superior to other knee replacement system prostheses. In fact, Arthrex promised patients would need fewer upkeep surgeries with the Arthrex iBalance TKA System than other implants because metal plates and screws did not have to be removed or replaced.

This particular feature made the knee prosthetic especially popular with patients, as revision surgery presents higher risks of infection, blood clots, bone loss, pain and swelling. Revision procedures and additional surgeries can leave to nerve and tissue damages as well as significant bone loss.

However, a number of injury reports have suggested the popularity may have been short-lived.

Injury Reports Cause Recall

The discovery of the irregular surface eventually spurred a Class II recall of the Arthrex iBalance TKA System containing the specific tibial trays. In the spring of 2016, healthcare facilities and their professionals had received Urgent Medical Device Recall notices regarding the Arthrex iBalance TKA tibial trays.

The recall reportedly affected over 2,300 tibial trays that had been distributed, with the recall notice asking that any unused Arthrex iBalance TKA tibial trays be returned to Arthrex.

Patients may sustain severe pain and limited mobility due to failure of a knee implant. The complications reported by patients included, but are not limited to:

• Inflammation
• Infection
• Bone Damage
• Nerve Damage
• Deep Vein Thrombosis
• Muscle Damage
• Loss of or Lack of Bonding between Knee Implant to Bone
• Tibial Loosening
• Disassociation of Insert
• Change in Component Position
• Patella-Femoral Tracking-Lateral Release (kneecap moves out of place)
• Knee Replacement Failure

Knee replacement is a commonly performed procedure in the United States, with over four million Americans having to undergo the surgery. This makes disclosure and clarity on the labels of these prostheses vital for the patient population and medical community.

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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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