BIOMET OFFSET TIBIAL TRAY 79MM

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2007 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. THE PATIENT UNDERWENT REIMPLANTATION OF THE LEFT KNEE ON (B)(6) 2007. ADDITIONALLY, THE PATIENT WAS REVISED ON (B)(6) 2011 DUE TO ASEPTIC LOOSENING AND PAIN. ALL COMPONENTS WERE REMOVED AND REPLACED. IT IS UNKNOWN WHICH COMPONENT HAD LOOSENED. THEN, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACER MOLDS. THE PATIENT UNDERWENT REIMPLANTATION OF THE LEFT KNEE ON (B)(6) 2013. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION¿ REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS NUMBER 11 OF 14 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-05189/05202).