The tibial tray of the Arthrex iBalance total knee implant has been recalled by the company over some possible manufacturing irregularities.

Arthrex iBalance Total Knee Basics

The Arthrex iBalance total knee implant was created as a treatment for multi-compartmental knee cartilage degeneration, a condition often caused by osteoarthritis or post-traumatic arthrosis. The device was meant to offer another option for patients besides the traditional total knee replacement. Though the Arthrex iBalance total knee implant was intended to reduce the need for further surgeries (knee replacement generally require additional surgery for metal plate and screw removal), complications of the Arthrex implant may lead patients to undergo revision surgery to correct the issues anyway.

Arthrex iBalance Total Knee Recall

The Arthrex iBalance total knee device recall was announced in March 2016 by the U.S. Food and Drug Administration (FDA). The FDA announcement was initiated after Arthrex’s own recall alerts, which the company sent out in February 2016.

Arthrex created what is known as an Urgent Medical Device Voluntary Recall, which was sent to distributors, surgeons, and medical facilities to warn them of the risks. According to the FDA, the reason Arthrex gave for its recall is that “[d]evices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.” While this sounds fairly innocuous, it essentially means that the product is not compatible with other components that have a rough texture.

The FDA site notes that 2,378 units were affected by the Arthrex iBalance total knee recall across the United States. Arthrex noted that the use of the device should be discontinued.

Patients who have reported problems with the Arthrex knee replacement device cite various complications, some of which have required revision surgery to correct.

Other Knee Replacement Recalls

The Arthrex knee replacement recall is not the only one of its kind. Other knee replacement devices have recently been hit with similar recalls due to serious side effects that, in some cases, required revision surgery. Of course, revision surgery itself brings on its own risks of complications and infection, as well as further medical expenses.

On top of the Arthrex iBalance total knee device, other devices that have been recalled in a similar fashion include the DePuy Attune system and the Exatech Optetrak system. Knee implants have been linked with a variety of side effects, including failure of components to bond, metal debris shedding, fracture, loosening, detachment, and pain. Many of these side effects have also necessitated revision surgery.

Filing an Arthrex iBalance Total Knee Lawsuit

Countless lawsuits have already been filed over total knee replacement devices. If you or someone you love has suffered due to Arthrex iBalance total knee failure, you may be able to file a lawsuit of your own.  While filing an Arthrex iBalance total knee lawsuit cannot undo the physical pain and emotional suffering caused by problems with the device, it can help to alleviate the financial burden caused by medical expenses, lost wages, and other costs associated with these injuries.

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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