OSS RS 12MM LS TIBIAL BEARING

Additional Manufacturer Narrative

(B)(4). D10: 161035, OSS RS AXLE, (B)(6) 161034, OSS RS POLY FEM BUSHINGS SET/2, (B)(6). 150476, OSS POLY TIBIAL BUSHING, (B)(6) 150493, OSS REINFORCED YOKE, (B)(6) PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND WAS SUBSEQUENTLY REVISED DUE TO A PERIPROSTHETIC FRACTURE FOLLOWING A FALL AND NEW COMPONENT WERE IMPLANTED. THE PATIENT DID WELL UNTIL DEVELOPING SLIGHT RECURVATUM WITH KNEE EXTENSION BEYOND NEUTRAL. THE PATIENT THEN UNDERWENT A POLYETHYLENE INSERT EXCHANGE, AND INTRA-OPERATIVELY THE BEARING WAS OBSERVED TO BE CRACKED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.