BIOMET ILOK PRI TIB TRAY 91MM

Description of Event or Problem

A PATIENT WAS IDENTIFIED IN THE JOURNAL ARTICLE TITLED, "SEVEN-YEAR SURVIVORSHIP AND FUNCTIONAL OUTCOMES OF THE VANGUARD COMPLETE KNEE SYSTEM;" WHERE IT WAS REPORTED THAT THIS PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, THE PATIENT UNDERWENT RIGHT KNEE MANIPULATION DUE TO ARTHROFIBROSIS ON (B)(6) 2004. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2005 DUE TO INFECTION. THE TIBIAL TRAY 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 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 ISO 11137-2. THE REFERENCED JOURNAL ARTICLE IS ATTACHED TO THIS MEDWATCH AND THE MANUFACTURER REPORT NUMBER OF THE MEDWATCH WHICH REPORTS ON ALL PATIENTS (IDENTIFIED AND NON-IDENTIFIED) MENTIONED IN THE JOURNAL ARTICLE IS 1825034-2014-08055. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015- 00590 / 00591).