FOUNDATION KNEE

Additional Manufacturer Narrative

THE ROOT CAUSE OF THE REVISION SURGERY ON (B)(6) 2012 WAS IDENTIFIED AS AN INFECTION. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2012. THE PATIENT WAS REVISED ON BOTH KNEES WITH A BILATERAL INFECTION. THIS COMPLAINT PERTAINS TO THE RIGHT KNEE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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 FOUNDATION KNEE INSERT WAS EXAMINED. THE PRODUCT USED IN THE ORIGINAL SURGERY RECEIVED AN ADEQUATE STERILIZATION GAMMA RADIATION DOSE BETWEEN 25-40 KGY AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF THE ORIGINAL SURGERY. A REVIEW OF THE DEVICE HISTORY RECORD, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOW THAT THIS DEVICE MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. NO INFORMATION WAS SUBMITTED WITH REGARD TO THE SEVERITY OF THE INFECTION. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO INFECTION THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT THIS INCIDENT WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

Description of Event or Problem

REVISION SURGERY- INFECTION IN RIGHT KNEE. THE SURGEON WASHED OUT THE KNEE AND IMPLANTED A SMALLER INSERT.