On March 12, 2015, the U.S. Food and Drug Administration (FDA) issued a Class 2 recall for all lots and sizes of Zimmer’s Persona Trabecular Metal Tibial Plate knee implant. This is one of the three major components used in a total knee replacement.
- More than 11,000 units were recalled worldwide.
- This knee replacement was approved for use in the U.S. on Nov. 29, 2012.
- According to the FDA, urgent medical device recall notices were issued to affected distributors, hospitals, and surgeons on Feb. 16, 2015, via mail.
- The reason Zimmer, the manufacturer, gave the FDA the recall is an “increase in complaints of loosening and radiolucent lines.” Radiolucent lines are seen only on X-rays and may indicate loosening. Symptoms of loosening can include an increase in knee pain, loss of motion, difficulty ambulating, giving way, popping, and instability. Revision surgery is required to replace the loose tibial component.