In February 2014, a new prosthetic knee replacement device was ushered into the marketplace through the U.S. Food and Drug Administration’s (FDA) 510(k) fast-track program—the Arthrex iBalance knee replacement system.

A company product recall and numerous reports of Arthrex iBalance failure to the FDA have brought into question the wisdom of this action.

What is the FDA 510(k) Fast Track Program?

When a pharmaceutical drug and medical device company wants to bring a new product to market under the fast track program, they need merely to prove that this product is similar enough to another drug or device already on the market as to be its equivalent.

Many have questioned this “loophole” involved in the fast track system. Patient advocates argue this loophole fails to hold manufacturers accountable for running drugs and devices through the gamut of clinical trials and safety studies.

Arthrex iBalance Failure Leads to Device Recall

A recall was issued in March 2016 that affected 2,300 units of the Arthrex iBalance. The stated reason for the recall was several components were found to have a smooth surface rather than a textured surface making them technically ‘incompatible’ with other parts.

Upon closer analysis of what seemed to be a minor issue, the lack of a textured surface could lead to incompatibility of components within a single implant system. While the entire knee replacement system includes femoral, patellar (knee cap), and tibial parts, the tibial tray whose stem is implanted into the bone and cemented relies upon the rough texture to help “grab” and encourage ingrowth of the tray support mechanism.

In some cases where total knee arthroplasty (TKA) patients have experienced complete Arthrex iBalance failure leading to the need to have it removed and replaced with an alternate device, surgeons have been able to pull the stem out of the bone with ease. This situation likely means that the tray was subject to movement while in a weight-bearing state leading to instability.

Common symptoms reported with Arthrex iBalance failure or failure of other knee prosthetics include:

• Inflammation/swelling
• Loss of range of motion
• Infections in the joint
• Fractures
• Movement of kneecap

The need to have a prosthetic system removed and replaced in an early revision surgery is not only prohibitively expensive, it exposes a patient to additional risks such as blood clots which can break off and systemically travel in the circulatory system, infections, and the possibility of bone tissue loss. Bone tissue loss makes the adherence of the replacement device all the more difficult and can lead to leg length discrepancies.

Because of the device recall, legal claims against the Arthrex company may carry additional weight in the patient’s favor. Filing a product liability lawsuit can help a person reclaim the costly investment in hospital and pre-surgical and post-surgical outpatient follow-up care as well as wages lost while recuperating and doing rehabilitation.

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