A woman from Arkansas recently filed an Arthrex lawsuit, alleging she suffered serious and permanent injuries from the Arthrex iBalance total knee replacement system.

The woman reportedly had the Arthrex knee replacement system implanted for typical treatment purposes and was not aware of the device’s allegedly defective nature when it was recommended.

Plaintiff Angela O. says she had the Arthrex iBalance total knee replacement system implanted in her left leg on Nov. 6, 2015, and reportedly experienced significant pain soon after. According to the Arthrex lawsuit, Angela started experiencing severe pain.

Along with continuous swelling and numbness in her left knee, Angela says she had to undergo revision surgery on April 5, 2016 to remove the Arthrex iBalance total knee replacement. She then says she had to undergo revision surgery again to have the Arthrex iBalance knee replacement removed again on April 18, 2016, after discovering the prosthetic was part of a massive recall.

According to the Arthrex lawsuit, surgeons noted that the tibial tray of the device was extremely loose and most likely contributed to the painful device complications she experienced.

The Arthrex lawsuit states that Angela did not discover these facts until after her last revision surgery, which prompted her to file legal action.

It is important to note that Arthrex iBalance TKA was marketed as an alternative option to conventional knee replacement systems. It was designed to reduce the need for additional surgeries to have metal plates and screws removed.

Overview of Arthrex iBalance Knee Recall

Arthrex Inc. issued a recall for the Arthrex iBalance TKA (Total Knee Arthroplasty) tibial tray in December 2015, after discovering the component could be incompatible with the rest of the prosthetic. The recall was reportedly initiated after it was discovered that the smooth texture on the TKA tibial trays in the implants had made it incompatible with earlier models with a rougher texture.

The Arthrex iBalance TKA tibial tray was created to help treat multi-compartmental knee cartilage degeneration caused by osteoarthritis or post traumatic arthrosis. According to the Arthrex website, the iBalance TKA System was developed “through years of research in understanding how to maintain the most normal knee kinematics.” The Arthrex iBalance TKA system is essentially supposed to be proved a flexible and efficient prosthetic for patients needing a knee implant.

Knee Replacement Systems

Approximately 4.4 million Americans have undergone knee replacement implants and it continues to be one of the most commonly performed orthopedic surgeries. However, a growing number of patients have started reporting problems from Arthrex and Exactech knee replacement products including:

• Pain
• Limited Range of Mobility
• Swelling
• Instability
• Infections
• Fractures
• Disassociation of Implant
• Inflammation
• Device Loosening
• Change in Component Position
• Patello-Femoral Tracking-Lateral Release (kneecap moves out of place)

These complications have spurred the companies to make several recalls due to design or construction defects of the implants. Even though these complications can be devastating to patients, Arthrex allegedly failed to disclose this information to Angela and other patients.

At all times relevant, Angela says she and her orthopedic physician had relied on the marketing materials and product information from Arthrex and had no reason to be wary of potentially serious complications.

This Arthrex Lawsuit is Case No. 6:19-cv-06026-SOH, in the U.S. District Court of Western Arkansas, Hot Springs Division.

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