Exactech Knees & Hips
Knees:
Exactech Opetrak and Opetrak Logic and Truliant:
In February of 2022 (and a quieter recall in 2021) Exactech recalled many thousands of its polyeth- ylene knee liners used in its knee implant due to premature failure. They claimed they had just recently learned that one of the packaging layers for the plastic insert has been out-of-specification which allows oxygen from the air to diffuse into the plastic insert prior to it being implanted which can cause the plastic to prematurely wear out and degrade. Knees are mostly Optetrak models and to a lesser extent, the Truliant tibial inserts (147,732 total since 2004).
Weitz & Luxenberg has filed more than two hundred cases in federal courts in the Southern, and Eastern District of New York and the District of New Jersey and the Eastern District of Pennsylvania and in New York Supreme Court. We filed the petition for a Multi-District Litigation (MDL) which Ellen Relkin argued last year resulting in an order creating an MDL.
W&L’s request for consolidation of cases filed in numerous federal courts into a multidistrict litigation (MDL) and to transfer actions against Exactech to the Eastern District of New York in Brooklyn was approved by the U.S. Judicial Panel on Multidistrict Litigation. The MDL is No. 3044 — In re: Exactech Polyethylene Orthopedic Products Liability Litigation. W&L partner and DMDL department head Ellen Relkin and associate attorney Danielle Gold have been appointed by the Court to leadership roles in the Exactech Polyethylene Orthopedic Products Liability MDL). Ms. Relkin is co-lead counsel and Ms. Gold serves on the Science and Experts subcommittee. To date, there are over 1000 cases pending in the MDL. On May 10, 2023, Weitz & Luxenberg and two other firms presented presentrf experts at a “Science Day” before the parallel state court liti9gaiton in Gainsecille Florida which was attended by the MDL Judge and Magistrate as well to educate the judges presiding over the litigation about the devices at issue, failure mechanisms and the resultant injuries. Discovery is actively ongoing. More than 200,000 documents exceeding one million pages have been produced and depositions have commenced. A bellwether plan has been agreed upon.
Hips:
Exactech Connexion GXL Liners (90,000 units)
GXL inserts manufactured since 2004 were also packaged in out-of specification (referred to here after as “non-conforming”) vacuum bags that do not contain a secondary oxygen barrier layer known as ethylene vinyl alcohol (EVOH), to resist oxidation. Oxidation can severely degrade the mechanical properties of the Connexion GXL polyethylene, which, can lead to both accelerated wear and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery. Further, the polyethylene was manufactured in a manner that was outdated and unlike the polyethylene used by other hip manufacturers. Exactech has changed its manufacturing now employing Vitamin E as a component to minimize oxidation.