BIOMET ILOK STEM TIB TRAY 63MM

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO SUBSIDENCE ON THE TIBIAL SIDE ASSOCIATED WITH INCREASED PAIN. ALL TIBIAL COMPONENTS WERE REMOVED AND REPLACED. PATIENT WAS REVISED AGAIN ON (B)(6) 2014 DUE TO ASEPTIC LOOSENING. THE FEMORAL COMPONENT AND TIBIAL BEARING WERE REMOVED AND REPLACED.

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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS; ¿INTEROPERATIVE AND/OR POSTOPERATIVE PAIN." AND ¿LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION AND EXCESSIVE ACTIVITY.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015- 01148 / 01149).