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. Multidistrict Litigation Panel said Oct. 7. (JPML).
Orthopedics This Week reported that the litigation centered on Exactech’s polyethylene components used in joint implants. The company issued a product safety alert in 2021 due to the synthetic compound used in its Connexion GXL hip systems.
Gainesville-based Exactech also issued a recall in 2021 due to the fact that its polyethylene inserts were packaged in off-spec vacuum bags that are resistant to oxygen 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.”
The plaintiffs allege that their implants failed prematurely due to the defective polyethylene component, necessitating the removal of the implant.
The specific devices that will be the focus of multidistrict litigation (MDL) include:
- Optetrak (knee)
- Truliant (knee)
- GXL connection (hip)
To date, plaintiffs have not filed any claims against Exactech regarding the company’s Vantage Total Ankle System.
In addition to the devices having to be removed prematurely, the plaintiffs allege that the devices caused inflammatory reactions requiring revision surgery.
JPML decided that Exactech’s cases would 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 United States 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 multiple reports that components of Exactech implant had become detached in the patients’ bodies, causing them pain, which required surgery to correct. Problematic polyethylene components can also cause joint dislocation, joint instability, bone degeneration and other side effects.