MEDICAL DEVICE RECALL – EXACTECH KNEES & ANKLES
By M.Ernat
In February 2022 Exactech issued a voluntary class II recall. These devices were implanted beginning in 2004, and the manufacturer is estimating there could be a 15% failure rate, which is significantly higher than the average failure rate on medical devices that have been recalled.
What’s the problem?
The issue is with the polyethylene inserts or liners used for both the knee and ankle implants. The inserts fit between metal surfaces of the devices. The manufacturer says the bags these inserts were housed in were not “up to spec, and have allowed oxygen into the bags and this has created degradation / oxidation of the liners.
Damages caused by this degradation / oxidation include early implant wear and the need for an earlier than usual revision. Injuries can range from pain and inflammation to, lysis or disintegration of the bone, and bone loss necrosis.
What’s going to happen?
This a new and emerging tort. An MDL (Multi-District Litigation) venue has not been selected, but the board that oversees the MDL process is expected to hear the merits of the case soon. The goal of an MDL is to conserve resources and hopefully foster consistent court rulings across different lawsuits that have similar legal issues. An MDL is a special federal legal procedure designed to speed up the legal process of handling complex cases by consolidating them into one federal court venue. Oftentimes, the judge tries to encourage the parties involved to move towards settlement.
What Products are Included?
Exactech polyethylene joint products recall include:
- OPTETRAK®Unicondylar Tibial Components
- OPTETRAK® All-polyethylene CR Tibial Components
- OPTETRAK® All-polyethylene PS Tibial Components
- OPTETRAK® B-Series Ps Tibial Insert
- OPTETRAK® CC Tibial Inserts
- OPTETRAK® CR Tibial Inserts
- OPTETRAK® CR Slope Tibial Inserts
- OPTETRAK® PS Tibial Inserts
- CUSTOM OPTETRAK® Angled PS Insert
- CUSTOM OPTETRAK® CC Tibial Insert
- OPTETRAK® HI-FLEX® PS Tibial Inserts
- OPTETRAK “MOMB” Non-Mod Molded Insert
- OPTETRAK® RBK PS Tibial Components
- OPTETRAK Logic® CR Tibial Inserts
- OPTETRAK Logic® CR Slope Tibial Inserts
- OPTETRAK Logic® CRC Tibial Inserts
- OPTETRAK Logic® PS Tibial Inserts
- OPTETRAK Logic® PSC Tibial Inserts
- OPTETRAK Logic® CC Tibial Inserts
- TRULIANT® CR Tibial Inserts
- TRULIANT® CR Slope Tibial Inserts
- TRULIANT® CRC Tibial Inserts
- TRULIANT® PS Tibial Inserts
- TRULIANT® PSC Tibial Inserts
What should I do if I had one of these products implanted?
It’s unlikely that you just happen to know the exact product that was implanted in you. However, Exactech was required to notify anyone with one of the above listed products about the recall. If you have received one of these letters, you are encouraged to contact VanDerGinst Law to discuss the viability of your case. There will be a number of factors that will impact cases, and one of our intake specialists can ask the right questions to make a determination on this.
The experienced attorneys and staff at VanDerGinst Law have been standing up for individuals against corporations for years, and we may be able to help you get compensation for your injuries from these medical implants.