Exactech Optetrak Knee Implant | 合法醫療器材資訊網

Exactech is a global medical device manufacturer best known for its knee replacement systems, such as the Optetrak knee implant, a device designed to relieve pain and increase range of motion in patients with knee joints damaged due to severe arthritis or traumatic injury. Exactech has been producing its Optetrak knee replacement system in various forms for more than 20 years, but some versions of the implant manufactured in 2011 and 2012 have been associated with an unexpectedly high rate of premature failure requiring revision surgery to correct. These devices featured what is known as a “finned” tibial tray, which some believe may not allow for adequate adherence to the surgical cement typically used in knee replacement surgeries.

Since 2011, the FDA has received reports of adverse events involving the Exactech Optetrak knee implant, a device that was fast-tracked through the agency’s 510(k) approval pro...