While knee joint replacement systems may come with added benefits such as pain-free stability and increased mobility, individuals who have been implanted with knee replacement systems such as the Arthrex iBalance total knee have complained of a multitude of problems. Complications linked to the Arthrex iBalance total knee include component loosening and reports of tibial failures.

There has been at least one recall with the Arthrex iBalance total knee announced by the company in December 2015. Additionally, the U.S. Food and Drug Administration (FDA) has received a large number of reports involving Arthrex iBalance total knee failures.

Individuals who have suffered complications and adverse side effects due to the product’s design defects may be eligible to obtain compensation. Individuals may be eligible if they have suffered any one of the following:

• Knee implant failure
• Revision surgery
• Loss of mobility
• Severe pain
• Loosening components

Overview: Arthrex iBalance Total Knee

The Arthrex iBalance TKA Tibial Tray is part of the Arthrex iBalance Total Knee Arthroplasty (TKA) System. It was approved to help treat multi-compartmental knee cartilage degeneration caused by post-traumatic arthrosis and osteoarthritis, and to help decrease the need for patients to undergo additional surgeries where they have screws and metal plates removed.

The device is composed of a tibial tray, tibial bearing components, femoral components and patellar components.

However, the device became approved through the FDA’s 510(k) fast track approval system in February 2014. This means that the manufacturer only had to illustrate that the Arthrex iBalance Total Knee was “substantially equivalent” to a device already on the market.

The company’s recall was announced by the FDA in March 2016. The announcement was made after the company discovered a smooth texture on the outer portion of the knee joint replacement implant when it was supposed to be textured. The smooth texture made the implant device incompatible as it could result in patient impacts, while a textured outer surface helps with the cement bonding process

Almost 2,300 units were impacted by the Arthrex iBalance Total Knee. Letters were sent to doctors, hospitals and distributors warning of the recall. This is classified as a Class 2 Device Recall.

Other problems associated with the Arthrex iBalance total knee included tibial plate bonding failures. In some cases, surgeons have had to pull out components of the device out of a patient’s body by hand. Others have also undergone revision surgery in many instances.

There are many adverse side effects and complications linked to the Arthrex iBalance total knee that have led individuals to file claims for design problems and malfunctions. Some allege the manufacturer may have held profits and revenue above patient safety and well-being by:

• Withholding impertinent safety information from surgeons, regulators and consumers
• Failing to warn about the associated risks linked to the Arthrex iBalance total knee
• Failing to properly and sufficiently research the design of the Arthrex iBalance total knee

Filing an Arthrex iBalance total knee lawsuit may help offset costs associated with a failing knee implant. Some of these benefits include helping with loss of future earnings, revision surgery, pain and suffering, permanent disability, long-term medical care, lost wages and hospital & medical bills.

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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