Exactech Optetrak complications linked to the knee replacement system have been frequently reported by patients. Some side effects and Exactech Optetrak complications have included: swelling, infection, instability problems, pain, mobility issues, inflammation, implant loosening, fractures, disassociation of implant, and Patello-Femoral Tracking-Lateral Release.

If you have suffered from Exactech Optetrak complications you may have a legal claim to pursue compensation such as for pain and suffering or medical bills.

Exactech Optetrak Complications

Exactech became one of the largest medical device manufacturers around the world in 1994. They are well known for their knee replacement implant, specifically the Optetrak knee replacement device. However, following its introduction to the market, the U.S. Food and Drug Administration (FDA) has received a number of complaints of premature device failure among other Exactech Optetrak complications.

Exactech’s Optetrak system was approved through what is known as the 510(k) process, a “fast-tracked” FDA approval process. Although the fast-track process allows companies to offer medical devices to consumers faster, it also means that the medical devices are subject to less rigorous testing.

Since the device’s approval, the FDA has received reports of premature failure of Exactech’s Optetrak system caused by wear and tear of the implant. Some common symptoms of a failing device include change in component positioning, reduced range of motion, and trouble balancing or instability.

The device’s failure has been blamed on a finned tibial tray insert that was reportedly not able to bear stress put on the joint. By 2012, the company noticed just how fast the Optetrak’s tibial tray feature was failing.

Claims have been made against the company alleging that proper testing was never conducted before the Optetrak knee replacement implant was placed on the market. Other allegations against the company accuse them of failing to conduct post-market tests or adequate follow-up tests, and failing to properly analyze data retrieved from pre-market tests.

For more than 30 years, Exactech has been making knee replacement systems. However, the Exactech Optetrak system was different because it contained a “finned” tibial tray which did not adhere to surgical cement.

Many patients have had to endure knee replacement revision surgery to help mitigate Exactech Optetrak complications and other adverse side effects suffered. By undergoing revision surgeries, many patients have also needed to have the implant removed.

Exactech Optetrak complications led the company to conduct a “silent recall” campaign to replace all faulty tibial trays with a new model. Additionally, a class 2 recall was announced by the FDA in September 2011.

A study conducted by Orthopaedics & Traumatology: Surgery & Research evaluated the device’s performance in 110 prostheses in 106 patients 25 months following knee replacement surgery. According to the study, the following evaluations were reported:

• 15% of patients expressed dissatisfaction/disappointment
• 22% mentioned the need to take painkillers regularly
• 20% mentioned signs of patellofemoral conflict
• 22% mentioned beginning signs of tibial implant loosening
• 13 implants required revision surgery

If you feel like you have suffered adverse effects, such as infection, fracture, or swelling after being implanted with an Exactech Optetrak system device, you may be eligible to file a knee replacement lawsuit.

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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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