By Kim Gale  |  June 12, 2018

Category: Legal News

Recalled Arthrex iBalance TKA Tibial Tray Can Wreak Havoc in Knee Replacement SystemHave you suffered knee replacement issues after being implanted with an Arthrex iBalance TKA Tibial Tray? If so, you could be eligible for compensation.

The Arthrex iBalance knee replacement system was designed to treat patients with multi-compartmental knee cartilage degeneration, which is often a result of osteoarthritis or post-traumatic arthrosis.

The Arthrex iBalance TKA Tibial Tray was recalled in December 2015 because the part was found to have a smooth texture when it was intended to have a rough texture.

The smooth texture was determined to be incompatible with the rest of the Arthrex iBalance Total Knee Arthroplasty (TKA) System, which was marketed as a superior product designed to reduce the need for more surgeries to remove metal components, including metal plates and screws.

Patients experiencing problems with their Arthrex iBalance Total Knee Arthroplasty System as a result of the Arthrex iBalance TKA Tibial Tray could face revision surgery to correct the issue.

In some cases, the Arthrex iBalance TKA Tibial Tray allegedly fails to properly bond, which doesn’t enable the knee replacement system to hold up under the stress of normal daily movement. Doctors report they have been able to pull the iBalance knee components apart by hand because of the failure of the Arthrex iBalance Tibial Tray to bond.

Problems Reported with Arthrex iBalance TKA

In a lawsuit against the device maker, plaintiff Mandy V. alleges that she received revision surgery had such a loose tibial tray that it fell out when the surgeon gently tugged on the part. Mandy had reportedly been in constant pain and suffered knee instability and hyperextension of the knee after she received the Arthex iBalance knee system in 2014. During the 2016 revision surgery, the surgeon was allegedly stunned that the components were so loose they nearly fell out without prompting.

She has since filed a lawsuit, which alleges, “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.”

Mandy is not alone. Other Arthrex iBalance TKA patients have reported serious issues, including severe pain, inflammation, reduced mobility, infection, bone damage, nerve damage, disassociation of the insert and knee replacement failure have resulted in the need for revision surgery.

Doctors received Urgent Medical Device Voluntary Recall letters from Arthrex in the spring of 2016. More than 2,300 Arthrex iBalance TKA Tibial Trays  were affected by the recall, and medical providers were asked to return any non-implanted tibial trays to Arthrex to make sure they were not used.

After the voluntary recall of the tibial trays was issued, the FDA followed up and announced the Class 2 medical device was to be removed from the market.

Mandy’s Arthrex iBalance TKA 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.

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