BIOMET ILOK PRI TIB 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, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00615 / 00617).

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY IN 2007 OR 2008. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO METALLOSIS, SUBLUXATION, AND POLY WEAR. THE FEMORAL, POLY BEARING AND TIBIAL TRAY WERE REMOVED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REQUESTED BUT NOT RETURNED BY HOSPITAL.