A woman from Arkansas alleges her Arthrex iBalance knee replacement system failed only a few months after it was implanted.

The claimant opted to file legal action after learning about a recent recall. She alleges the knee replacement system was defective, and that its promotional materials had failed to warn her against potential device complications.

Plaintiff Angela O. says she had the Arthrex iBalance knee replacement system implanted for typical treatment purposes in her left knee on Nov. 6, 2015, and reportedly suffered no initial device complications.

The iBalance knee replacement system was marketed as an alternative to traditional knee prostheses. It was reportedly designed in a way that would reduce the need for additional surgeries, which other implants require to replace metal plates and screws in the prosthetic. However, numerous patients have reported serious knee replacement complications soon after having the device implanted.

Angela was reportedly one of these patients. She alleges she began experiencing pain, swelling, and numbness in her left knee. Angela says she eventually had to undergo total knee revision surgery in April 2016 to removed the knee replacement system. She says she continues to suffer debilitating pain to this day.

Angela opted to file legal action against Arthrex after learning the company recalled the tibial tray of the Arthrex iBalance system in late 2015. The tibial tray implanted in Angela was reportedly a part of this recall, but Angela says she and her physicians had no way of knowing this at the time it was recommended.

Overview of Arthrex iBalance TKA Tibial Tray Recall

The Arthrex iBalance TKA (total knee arthroplasty) Tibial Try was recalled by Arthrex in December 2015, after it was discovered a smooth texture on the outer part of the knee implants could make it incompatible with previous knee replacement models that have a rough texture.

The FDA says it received an Urgent Medical Device Voluntary Recall letter from the company on Feb. 5, 2016, stating that these devices should not be implanted and should be returned to the manufacturer.

The Arthrex TKA Tibial Tray is a component of the Arthrex iBalance knee replacement system, which was supposed to help treat multicompartmental knee cartilage degeneration caused by osteoarthritis or past traumatic knee injuries.

Knee replacement surgery is one of the most commonly performed orthopedic procedures in the United States, with surgeons often having to removed damages bone and cartilage before implant the prosthetic.

Approximately 4.4 million Americans have undergone knee replacement surgery, but several of these patients have reportedly suffered serious injuries. These injuries include but are not limited to:

• Debilitating Pain
• Limited Mobility
• Swelling
• Infection
• Fractures
• Disassociation of Implant
• Inflammation
• Loosening of Knee Replacement System Implant
• Patello-Femoral Tracking Lateral Release (kneecap moves out of place)

Even though these complications can be devastating to patients, Angela says Arthrex failed to disclose this information to the public in a timely manner. Angela states she would not have agreed to have the Arthrex iBalance system implanted if she had been aware of the allegedly defective nature of the device.

This Arthrex Knee Replacement 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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