In an Arthrex knee recall in the first quarter of 2016, the Federal Food and Drug Administration (FDA) announced that the iBalance TKA Tibial Tray was to be removed from market circulation.

This announcement by the medical drug and device oversight agency came on the heels of a voluntary recall by the Arthrex company headquartered in Naples, Florida.

The Arthrex knee recall was initiated by the manufacturer because of variances in the texture to the outer surface of the component metal. Previously, the tray had been textured, but a new lot of devices were found to have a smooth texture which was believed to be potentially problematic if implanted.

This Arthrex knee recall of the iBalance TKA Tibial Tray affects 2,278 units on the market. It is not clear how many of this figure have been surgically implanted in patients.

Knee replacement prosthetics were created to help mimic the mechanics of the natural knee in individuals suffering from traumatic injury to the joint or severe arthritic conditions requiring advanced surgical intervention.

A prosthetic unit or system for the knee usually involves a tray or plate that sits on top of the major lower leg bone or tibia and an artificial articulating end of the upper leg bone or femur. There are also sometimes plastic joint liners that mimic the cartilage found in the knee known as the meniscus.

The iBalance TKA Tibial Tray was fast-tracked through the FDA approval process in December 2013. The fast-track process is frequently referred to as a loophole and is called the FDA 510(k) clearance process.

This controversial “fast-lane” process allows for a medical device company to apply for and obtain clearance for a medical device if they can prove that the device is substantially equivalent to another product on the market already.

Many knee replacement prosthetic components have had problems upon implantation. These problems have forced surgical recipients to get the parts removed in an additional surgery known as the knee revision surgery.

Knee revisions that are done early can predispose a patient to blood clots known as deep vein thrombosis (DVT) or pulmonary embolism (PE) which can be deadly. They can also make a secondary prosthetic implant more difficult due to bone or other tissue loss.

The Arthrex knee recall may help prevent further implantations of this potentially defective medical device but does nothing for those that have already had the prosthetic installed. Some of the symptoms and complications a patient might experience if they have a faulty prosthetic knee component might be:

• Severe pain and inflammation
• Tibial tray peg disassociation from the bone
• Change in position of the components
• Infection in the joint
• Lack of knee tracking
• Bone and muscle damage

If you or a loved one have experienced any of the above as a result of the iBalance TKA Tibial Tray, you may qualify for a free consultation with a knowledgeable medical device attorney. You may be entitled to compensation for your pain, suffering, and financial loss.

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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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