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FDA Receiving Frequent Reports of Exactech Optetrak Knee Implant Failure

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According to the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database, there have been numerous reports of early device failure connected with the Exactech total knee replacement implant system.

The Exactech Optetrak tibial tray, one of the device’s components that has been linked to potential device failure, has been found to be prone to excessive wear and tear and the subject of an FDA Class 2 Device Recall. Some patients who received the Exactech implant later had to undergo revision surgery to remove and replace the failed knee implant because it did not adequately adhere to the patient’s bone, resulting in loosening, instability, pain, and infection. Revision surgeries are necessary when allegedly defective knee implants fail, and companies that have issued knee implant recalls because of high failure rates include DePuy, Arthrex, and Exactech.

A study recently published in the medical journal Orthopaedics & Traumatology: Surgery & Research reviewed the results of 106 patients to determine how the Exactech total knee replacement system was working for patients 25 months after knee replacement surgery. The researchers found that tibial loosening was occurring at the cement-tibial-implant component of the device, resulting in fragmentation, device wear, and the following complications:

Lawsuits are being filed around the U.S. alleging injuries related to the Exactech Optetrak knee replacement system. The law firm Childers, Schlueter & Smith, LLC initiated the first such suit filed in the state of Georgia on September 27. The lawsuit claims that Exactech designed, manufactured, and sold the defective Optetrak device and concealed the risk associated with the implant from medical professionals as well as patients, who suffered severe and permanent injuries as a result.

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