BIOMET OFFSET TIBIAL TRAY 79MM

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO INFECTION. THE TIBIAL TRAY AND TIBIAL BEARING WERE REMOVED AND A CEMENT SPACER MOLD WAS IMPLANTED. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2012 WHERE ALL COMPONENTS WERE REMOVED AND A TOTAL KNEE SYSTEM WAS IMPLANTED. PATIENT UNDERWENT A THIRD REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. DURING THE PROCEDURE, SURGEON HAD DIFFICULTY REMOVING THE TIBIAL OFFSET ADAPTOR AND TIBIAL STEM AS THE STEM HAD BEEN CEMENTED IN. THE COMPONENTS WERE REMOVED AND A 60 MINUTE DELAY OCCURRED DURING THE PROCEDURE.

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08920 / 08925).