Litigation over Florida-based Exactech’s medical devices used in ankle, hip and knee replacement surgeries will be consolidated in federal court, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ruled Oct. 7.
Orthopedics This Week reported that the litigation centers on Exactech’s polyethylene components that are used in joint implants. The company issued a product safety alert in 2021 because of the synthetic compound that’s used in its Connexion GXL hip systems.
Headquartered in Gainesville, Exactech also initiated a recall in 2021 due to the fact that its polyethylene inserts were packaged in out-of-specification vacuum bags that are oxygen resistant but do not contain a secondary oxygen barrier of ethylene vinyl alcohol.
The company then issued a recall earlier this year to include “additional Connexion GXL hip liners and other polyethylene liners.”
Plaintiffs allege that their implants have prematurely degraded because of the faulty polyethylene component, necessitating the removal of the implant.
The specific devices which will be the focal point of the multidistrict litigation (MDL) include:
- Optetrak (knee)
- Truliant (knee)
- Connexion GXL (hip)
To date, plaintiffs have not filed claims against Exactech over the company’s Vantage Total Ankle System.
In addition to the devices needing to be removed prematurely, plaintiffs allege that the devices have caused inflammatory reactions that require revision surgery.
The JPML ruled that Exactech cases will be transferred to the Eastern District of New York, which is based in Brooklyn. Judge Nicholas G. Garaufis will preside over the MDL, which currently involves 75 cases.
The U.S. Food And Drug Administration (FDA) issued a recall of approximately 200,000 Exactech implant devices in August 2021. The recall was announced after the agency received several reports that Exactech implant components had become loose in patients’ bodies, causing them pain, which required surgery to correct. The problematic polyethylene components may also cause joint dislocation, joint instability, bone degeneration and other side effects.