BIOMET OFFSET TIBIAL TRAY 71MM

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, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS¿ AND ¿LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION AND EXCESSIVE ACTIVITY.¿

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT TOTAL KNEE ARTHROPLASTY ON LEFT SIDE ON (B)(6) 2011 AND RIGHT SIDE (B)(6) 2011. SUBSEQUENTLY, PATIENT UNDERWENT MANIPULATION OF THE LEFT KNEE DUE TO ARTHROFIBROSIS ON (B)(6) 2011 AND (B)(6) 2011. PATIENT UNDERWENT A LEFT REVISION ON (B)(6) 2013 DUE TO INSTABILITY AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENTS WHICH WERE REMOVED AND REPLACED.