BIOMET OFFSET TIBIAL TRAY 71MM

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO INFECTION. ALL PRODUCTS WERE REMOVED AND CEMENT SPACER MOLDS WERE USED TO COMPLETE 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 COMPLAINT RELATED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ THIS REPORT IS NUMBER 7 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015- 01685 / 01691).