Exactech Knee Lawsuit Filed Over Premature Failure of ... | 合法醫療器材資訊網

2020年8月19日—AnOptetrakkneereplacementsystemlawsuitclaimsthemanufacturer,Exactech,releasedadefectivedesignwhichcausedamantoundergo ...

As early as 2012, researchers published a study in Orthopaedics and Traumatology that warned of potential failures after just 25 months. In 2016, an Australian joint registry warned of higher than usual failure rates after just three years, and tied with another implant for the worst failure rate, 6.6%, after just five years. At seven years, the Optetrak had the worst failure rate of any implant on the market in 2016, with a mean failure rate of 7.9%.

According to the complaint, problems with Exactech Optetrak knee appear to be related to the use of a finned tibial trays. Although adverse event reports have been filed with the FDA for years, lawsuits indicate that instead of issuing a warning to customers or facing the bad press of a full Exactech Optetrak recall, the manufacturer engaged in a “silent recall,” by slowly replacing the finned tibial trays with a sturdier design it...