FOUNDATION KNEE

Additional Manufacturer Narrative

AN AGENT INFORMED DJO SURGICAL OF A REVISION SURGERY INVOLVING A REPLACEMENT OF A STANDARD TIBIAL INSERT AND PATELLA. THE AGENT REPORTED "PT DEVELOPED INFECTION IN KNEE, COMPLAINED OF PAIN AND SWELLING IN KNEE. STAGE 1 REVISION POLY PATELLA/TIBIA INSERT." THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2010 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2011. THERE WAS NO DELAY IN SURGERY, AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS FOR THE DEVICE WERE EXAMINED. THE REPORTED DEVICES USED IN THE ORIGINAL SURGERY RECEIVED AN ADEQUATE 25-40KGY GAMMA IRRADIATION STERILIZATION DOSE AND WERE WITHIN THEIR RESPECTIVE EXPIRATION DATE AT THE TIME OF SURGERY. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THERE WERE NO OTHER COMPLAINTS FOR INFECTION FILED AGAINST THIS PART NUMBER. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORDS, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOW THAT THE REPORTED DEVICES MET STERILIZATION, DESIGN, AND MFG REQUIREMENTS. THE ROOT CAUSE OF THE REVISION SURGERY ON (B)(6) 2011 WAS IDENTIFIED AS AN INFECTION. NO INFO WAS SUBMITTED WITH REGARD TO THE ORGANISM INVOLVED IN THE INFECTION OR THE SEVERITY OF THE INFECTION. IT IS UNK IF THE PT WAS INVOLVED IN ANY OTHER ACTIVITIES THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR HAD ANY PRE-EXISTING CONDITIONS. IT IS UNK IF THE PT WAS COMPLIANT WITH POST SURGICAL INSTRUCTIONS.

Description of Event or Problem

REVISION SURGERY - THE PT DEVELOPED AN INFECTION IN THE KNEE. THE PT COMPLAINED OF PAIN AND SWELLING IN THE KNEE. THIS IS A STAGE ONE REVISION POLY PATELLA/TIBIA INSERT.