A class action investigation has been launched against a number of knee replacement prosthetic manufacturers, including the manufacturer behind the Arthrex iBalance TKA tibial tray.

The Arthrex iBalance TKA tibial tray has been linked to a number of serious complications, which have reportedly resulted in device failure and forced many patients to undergo revision surgery.

The Arthrex iBalance TKA tibial tray was recalled in December 2015, after Arthrex found the device component was incompatible with certain knee replacement models and would not be suitable for patients.

More specifically, the recall was initiated because the “devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.” Essentially, the smooth surface of certain Arthrex iBalance TKA tibial tray components may not be compatible with earlier models with rougher textures.

In addition, Urgent Medical Device Voluntary Recall letters were sent to healthcare facilities and physicians across the United States, warning that over 2,300 Arthrex iBalance TKA tibial tray components were affected by the recall.

The letters asked doctors and other healthcare professionals to return any unused tibial trays to the company and to not recommend these devices to patients needing knee replacement surgery, to prevent unsafe prostheses from being implanted inside patients.

Arthrex is just one of a number of knee replacement companies that had to conduct a market recall of certain products to prevent harm to patients. Approximately 4.4 million patients in the United States have undergone knee replacement surgery, but this number is increasing and so are the injury reports regarding faulty prosthetic systems.

Considering that knee replacement surgery is one of the more commonly performed prosthetic procedures in the country, the recent problems associated with these knee replacement systems is very concerning for the patient population and medical community.

Overview of Arthrex iBalance TKA Tibial Tray Problems

The Arthrex iBalance TKA tibial tray was approved by the FDA to enter the market in 2013, through the agency’s fast track approval process.

This prosthetic component earned quick approval for reportedly being superior to traditional total knee replacement prosthetic components, especially for patients suffering from multicompartmental knee cartilage degeneration caused by osteoarthritis or post traumatic arthrosis.

This knee replacement component was supposed to reduce the need for additional surgeries that are often needed to have metal plates and screws removed. However a number of patients reportedly suffered complications including, but not limited to:

• Pain
• Mobility Trouble
• Swelling
• Instability
• Infections
• Fractures
• Disassociation of Implant
• Inflammation
• Device Loosening
• Shifts in Component Position
• Kneecap Shifting Out of Place

Patients who suffer these complications will most likely have to undergo revision surgery, which is considered riskier than the initial implant surgery.

Patients who were forced to undergo revision surgery that was allegedly due to the defective nature of the Arthrex iBalance TKA tibial tray may be eligible to participate in the class action investigation. Potential claimants can seek several damages, including negligence and failure to warn, which can be used to compensate for medical expenses.

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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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