COUNTRY OF COMPLAINT: (B)(6) ON 05/19/2016 BASIC INFORMATION WAS RECEIVED REGARDING 1 YEAR POST OPERATIVE BREAKAGE OF A KNEE PROSTHESIS. THERE WAS NO INFORMATION RECEIVED REGARDING THE INVOLVED PRODUCT NUMBER, THEREFORE THE COLLECTIVE PRODUCT CODE WAS USED WHICH GIVES REFERENCE TO THE POTENTIALLY INVOLVED SYSTEM. INFORMATION IS BEING REQUESTED AND UPDATE OF THIS REPORT WILL BE MADE WHEN RECEIVED. *IT SHOULD BE NOTED THAT THE PRODUCT CODE SELECTED IS BEING SELECTED IN ORDER TO FULFILL THE REQUIREMENTS OF THIS FORM AND MAY NOT BE THE ACTUAL PRODUCT CODE; THE TYPE OF KNEE PROSTHESIS INVOLVED IS UNKNOWN. IT IS NOT POSSIBLE TO VERIFY THE PRODUCT CODE.
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Patient 1
INVESTIGATION: DUE TO THE CIRCUMSTANCE THAT WE DID NOT RECEIVE THE IMPLANTS, AN INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. THIS IS THE FIRST CASE DESCRIBING FEMORAL STEM FRACTURE. CONCLUSION AND ROOT CAUSE: A DEFINITIVE CONCLUSION AND ROOT CAUSE COULD NOT BE DETERMINED BECAUSE AN INVESTIGATION WAS NOT POSSIBLE. ON THE BASIS OF THE X-RAY PICTURES, NEITHER A FRACTURED STEM NOR A FAILURE OF THE ENDURO SYSTEM CAN BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE THAT THE PATIENT'S BONE SITUATION WAS NOT OPTIMAL. IN SUCH CASES THE FIXATION BETWEEN THE IMPLANT AND THE BONE MIGHT NOT BE SUFFICIENT AND IT MAY NOT OSSIFY. NO CAPA IS NECESSARY.