BIOMET OFFSET TIBIAL TRAY 79MM

Description of Event or Problem

LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009 AND FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO ALLEGED TIBIAL LOOSENING. PATIENT'S LEGAL COUNSEL ALLEGED THAT A SECOND REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO DISASSOCIATION OF THE TIBIA STEM FROM THE TIBIA TRAY AND POSSIBLE INFECTION. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATE AND THAT THE TIBIAL COMPONENTS WERE REMOVED DURING THE REVISION PROCEDURE ON (B)(6) 2011. AN INVOICE COULD NOT BE LOCATED FOR THE REVISION PROCEDURE THAT WAS ALLEGED TO HAVE OCCURRED ON (B)(6) 2012. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." AND "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-00509 / 00513).