The Exactech knee, hip, and ankle implants are complex medical devices that are composed of various parts designed to replace damaged joints in the human body. A standard total knee replacement is made up of four parts: the femoral component, the tibial tray, the patellar component, and the tibial polyethylene insert. On the other hand, a standard total ankle replacement is made up of three parts: the tibial component, the talar component, and the polyethylene insert.
Exactech discovered a significant issue with the polyethylene insert used in both total knee and ankle replacements, which acts as a cushion for the replaced joint. Specifically, the company found that one of the packaging layers for the polyethylene insert did not comply with specifications, permitting oxygen to penetrate the plastic insert before its implantation.
This oxygen infiltration could trigger oxidation, leading to premature wear of the implant components and causing damage to the plastic after it is placed in the patient's body. Without the plastic insert, there is no cushioning to absorb the impact of movement, causing pain and injury to the patient.
In August 2021, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of various models of Exactech knee and ankle replacements with polyethylene components and inserts, due to the risk of device failure. Then, in February 2022, Exactech took additional action and expanded the recall to include all polyethylene liners used in knee and ankle replacements. Certain orthopedic hip-implant components were also recalled due to similar issues.