BIOMET OFFSET TIBIAL TRAY 2.5MM ADAPTOR

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO LOOSENING OF THE TIBIA BETWEEN THE TIBIAL PLATE AND THE OFFSET TIBIAL TRAY ADAPTER. THE LOCKING SCREW THAT CONNECTS THE TIBIAL PLATE AND TIBIAL TRAY ADAPTER WAS NOT ASSEMBLED DURING THE INITIAL IMPLANTATION.

Additional Manufacturer Narrative

THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOUR STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY". THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00526 / 00527).

Additional Manufacturer Narrative

REVIEW OF EXPLANTED DEVICE FOUND NUMEROUS GOUGES AND DENTS. WITHOUT THE PROPER ASSEMBLY OF THE LOCKING SCREW THE TIBIAL TRAY WOULD VERY LIKELY LOOSEN. THIS FOLLOW-UP REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00526-1 / 00527-1).