Exactech, Inc. has recalled certain polyethylene components of its hip, knee and ankle replacement devices. These components, specifically identified below, experience early failure due to early excessive wear after initial implant surgery and may require additional surgery to replace the device and repair damage to bone and soft tissue.
Explanation of the ExacTech Hip Component Recall
In July 2021, ExacTech recalled its Connexion GXL acetabular liner. A hip liner is the component inserted into the artificial hip socket or cup that interfaces with the femoral head or ball. The ExacTech hip liner is made of irradiated ultra-high molecular weight polyethylene (UHMWPE). A study by the Department of Orthopedics and Rehabilitation at the University of Florida College of Medicine determined that the Connexion GXL liner “may be prone to a high rate of early failure from wear and severe secondary osteolysis [bone degeneration].” A second study by surgeons at the Hospital for Special Surgery in New York, found osteolysis in patients five years after index hip replacement surgery where the ExacTech Connexion GXL acetabular liner was implanted.
Explanation of the Knee Component Recall
ExacTech manufactures a tibial polyethylene (plastic) insert. This is the plastic that fits between the femoral and tibial components and acts as the “new” cushion or cartilage for the replaced knee joint. ExacTech has determined that “most of [its] inserts manufactured since 2004 were packaged in out-of-specification (or “non-conforming”) vacuum bags that are oxygen resistant but do not contain a secondary barrier containing ethylene vinyl alcohol that further augments oxygen resistance.” The use of the non-conforming bags enables increased oxidation of the UHMWPE tibia insert, that over time degrades the insert. This leads to accelerated wear debris production and bone loss and/or component cracking/fracture. ExacTech initiated a recall of its knee component in August 2021.
Explanation of the Ankle Component Recall
ExacTech ankle replacement systems have been sold since 2017 and marketed as the Vantage Total Ankle System. Like the knee component and the GXL hip implant liner, the polyethylene inserts for the Vantage System are failing due to excessive wear and resulting complications.
Adverse Effects Caused by these Products
Patients that have been implanted with these devices may experience pain, tissue damage, loosening of the components, stiffness, limited mobility, and osteolysis (bone loss). Revision surgery and repair are highly likely. Patients with these devices need to be assessed promptly.