Exactech Bone Cement & Knee / Hip Implant Packaging Defect Products Liability MDL

Exactech, Inc., a Florida-based orthopedic device manufacturer, issued a sweeping recall beginning in 2021 and expanding significantly in 2022, ultimately covering over 147,000 knee, hip, and ankle replacement devices distributed in the United States and internationally. The recall was triggered by the discovery that the polyethylene inserts inside the implants—the plastic bearing surfaces that allow joint movement—were packaged in bags that failed to meet the company's own specifications for oxygen barrier protection. As a result, the implants were exposed to elevated levels of oxygen during storage, causing the plastic components to oxidize and degrade far more rapidly than normal, leading to premature implant failure.

Patients who received the defective implants have reported symptoms including severe joint pain, swelling, instability, reduced range of motion, and bone loss (osteolysis) caused by plastic debris particles shed from the degrading implants. Many have been required to undergo painful and expensive revision surgeries to remove and replace the failed devices. The federal MDL, consolidated in the Eastern District of New York, is proceeding through bellwether trials to help establish damages frameworks for the thousands of plaintiffs. Exactech was acquired by private equity firm TPG Capital, and litigation has also targeted whether the parent company bears liability for the defect. As of 2025, individual cases are being resolved through ongoing negotiations and early settlements.