A New York woman is suing orthopedic devicemaker Exactech, alleging the company knew about issues with its Optetrak total knee implant.
Five things to know:
1. Linda Safran had a total left knee replacement Feb. 18, 2014, and received Exactech's Optetrak knee implant, according to the lawsuit filed Dec. 22 in the U.S. District Court for the Southern District of New York. In May 2022, she had an MRI that revealed signs of debris in her right knee, and a CT scan found osteolysis around her implant.
2. Ms. Safran had revision surgery in June 2022 to remove the failed knee implant. The surgeon who operated on her found the femoral component was loose and identified osteolysis of both femoral condyles and osteolysis of the posterior condyles and intercondylar notch. The lawsuit alleges the complications were due to premature wear of the tibial insert.
3. The lawsuit alleges Exactach ignored warnings about issues with the Optetrak device, and several other patients have needed revision surgery to address defective implants, the lawsuit said. The company by 2012 had clinical evidence that Optetrak devices had high failure rates, but Exactech didn't change labeling, marketing or product inserts to warn patients or physicians of risks related to Optetrak, according to the complaint.
4. A recall notice "admits that the recall and problems arose from failure to properly package the polyethylene insert component of the Optetrak device," the lawsuit said. Exactech issued a nationwide recall in February 2022, saying most inserts since 2004 were packaged improperly.
5. Ms. Safran's lawsuit is seeking compensation for losses related to her medical care.
Note: Exactech didn't immediately respond to Becker's request for comment.