A Class 2 recall has been issued for a component of Zimmer’s Persona knee implant, the Trabecular Metal Tibial Plate/Persona TM Tibia. According to a recall notice dated March 12, 2015 on the U.S. Food and Drug Administration’s (FDA’s) website, the recall was issued due to growing reports of radiolucent lines and loosening.
The recalled component is designed to be used without cement. The tibial plate is intended to provide proper fixation to the bone and can be used with various components. A growing number of complaints indicate that the plate does not always function as promised, however. Radiolucent lines, which are spaces in the between the component and the bone or between components, were cited as a main reason for the recall. Radiolucent lines are frequently caused by an implant part not being secured correctly; this allows fluid, tissue or debris to fill the gaps and cause osteolysis bone damage, implant loosening and failure.
A Class 2 recall indicates that the device “may cause temporary or medically reversible adverse health consequences.” If the tibial plate of a knee implant loosens, it may prompt the patient to undergo a costly and painful revision surgery. The notice states that 11,658 Persona devices have been distributed to 25 states. Urgent Medical Device Recall letters were distributed on February 16, 2015. “Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately. The Inventory Return Certification Form should be completed and returned along with the recalled product.” the notification stated.