OFFSET TIB TRAY 5.0MM ADAPTOR

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN. IT WAS FURTHER REPORTED PATIENT IS STILL EXPERIENCING PAIN. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION ON (B)(6) 2013 WHERE COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. ON (B)(6) 2013 PATIENT UNDERWENT A SECOND REVISION PROCEDURE WHERE SPACER MOLDS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. ON (B)(6) 2013 PATIENT UNDERWENT A THIRD REVISION PROCEDURE WHERE SPACER MOLDS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. ON (B)(6) 2014 PATIENT UNDERWENT A FOURTH REVISION PROCEDURE WHERE THE SPACERS MOLD WERE REMOVED AND A TOTAL KNEE WAS REIMPLANTED. ON (B)(6) 2014 ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. IN (B)(6) 2014 PATIENT'S LEG WAS AMPUTATED DUE TO SEVERE INFECTION.

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. 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: UNDER POSSIBLE ADVERSE EFFECTS: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 7 OF 14 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-08260 & 08672 - 08684).