A woman and her husband have filed a lawsuit over a failed Arthrex iBalance knee replacement system.

Plaintiff Mandy V. underwent total knee replacement surgery on both knees in December 2014. The left knee healed well, but Mandy says she experienced pain, swelling and instability in the right knee that resulted in her exhibiting an abnormal gait.

According to the Arthrex iBalance lawsuit, “A bone scan and x-rays showed clear evidence of component loosening and failure with constant increasing pain and discomfort with hyperextension and medial lateral instability.”

In July 2016, Mandy underwent a revision of her failed Arthrex iBalance knee implant. Her surgeon said the tibial component was so loose it came out by just giving it a pull.

Arthrex iBalance Complaint Alleges Design Defects

Mandy claims she has suffered severe and permanent injuries, causing her to incur lost wages, lost earning capacity and expenses related to medical, hospital, rehabilitative and medication needs.

She has endured severe pain, mental anguish, loss of enjoyment of life and her husband has lost her companionship, all due to the permanent injuries brought about by the failed Arthrex iBalance knee implant.

The Arthrex iBalance complaint alleges the knee implant was “defectively designed and/or manufactured in that the iBalance knee implant failed to withstand normal and reasonable use…” and Arthrex should have known the knee implant system “would be used by users without any knowledge of their product defects and inherent dangers and without any inspection for dangers and defects.”

The Arthrex iBalance lawsuit states that the knee implant is “more dangerous than an ordinary consumer or user would expect” and the product’s benefits “do not outweigh the risks inherent in the design and configuration of the iBalance knee implant.”

Arthrex Tibial Tray Recall Issued

A recall of the Arthrex tibial tray, a component of the iBalance system, was issued in December 2015.

The Arthrex iBalance knee replacement system had been fast-tracked through the FDA in 2013 and was marketed as a revolutionary implant that would require fewer revision surgeries than past knee implant systems.

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 due to too many failure complaints.

Serious issues including severe pain, inflammation, reduced mobility, infection, bone damage, nerve damage, disassociation of the insert and knee replacement failure resulted in revision surgery for many Arthrex iBalance patients.

If you or someone you love has undergone knee replacement surgery and has endured a revision surgery due to a failed Arthrex iBalance knee implant, you could benefit from speaking with a lawyer regarding your legal options.

The Arthrex iBalance Lawsuit is Case No. 2:17-cv-00869-MHW-EPD in the U.S. District Court for the Southern District of Ohio, Eastern Division.

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