An Arthrex iBalance recall could affect thousands of knee implant patients.

The Arthrex iBalance TKA Tibial Tray was the subject of a voluntary recall issued by Arthrex in December 2015. Part of the Arthex iBalance Total Knee Arthroplasty (TKA) System, the tibial tray was found to have a smooth texture unlike previous models. The smooth textured tibial tray has led to the need for several knee revision surgeries, and led to the Arthrex iBalance recall.

Doctors and hospitals received Urgent Medical Device Voluntary Recall letters from Arthrex in the spring of 2016. More than 2,300 trays were affected by the recall, and medical providers were asked to return any non-implanted tibial trays to Arthrex to ensure they were removed from the market.

After the voluntary recall was issued, the FDA followed up and announced the Class 2 medical device was to be removed from the market.

The FDA actually had fast-tracked approval of the Arthrex iBalance knee replacement system in 2013, and Arthrex marketed the iBalance TKA as a better option over conventional total knee replacement surgery. Marketing materials made it clear the unique design reduced the need for subsequent surgeries to remove metal plates and screws.

Unfortunately, knee replacement patients have reported suffering complications. More patients than anticipated have needed revision surgeries.

Arthrex iBalance Recall Due to Several Issues

The Arthrex iBalance knee replacement system was designed to treat patients with multi-compartmental knee cartilage degeneration, which is often a result of osteoarthritis or post-traumatic arthrosis.

Patients who have endured painful complications have needed revision surgeries due to the defective tibial tray covered by the Arthex iBalance recall.

Among the serious issues facing patients affected by this defective part are:

• Severe pain
• Inflammation
• Reduced mobility
• Infection
• Bone damage
• Nerve damage
• Disassociation of the insert
• Loosening
• Hyperextension
• Knee instability
• Total knee replacement failure

In at least one case, a woman who underwent revision surgery had the tibial component easily fall out when the surgeon gave it a gentle tug. She had suffered increasing pain, instability and hyperextension of that knee since she had received the iBalance system in 2014. When she had the revision surgery in 2016, her surgeon did not expect to find the parts to be so loose they nearly fell out on their own.

Patients suffering from tibial tray issues under the Arthrex iBalance recall could endure severe and permanent injuries even after revision surgery. Lasting effects could include lost wages, lost earning capacity and unexpected expenses related to medical, hospital, rehabilitative and medicinal needs.

The Arthrex iBalance recall would not have been necessary if adequate testing and quality inspections for inherent dangers would have been completed before the parts were placed on the market. Patients trust the knee implant systems they receive have been thoroughly tested and are state-of-the-art mechanisms that will improve their mobility and their lives.

If you have received a knee implant surgery with parts covered by this Arthrex iBalance recall, you could benefit from speaking with an attorney regarding your legal options.

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.

Learn More