TIBIAL COMP KIN HINGE KNEE

Description of Event or Problem

IT WAS REPORTED THAT MRS DISTAL FEMUR WITH ALL POLY TIBIA WAS REMOVED DUE TO INFECTION.

Additional Manufacturer Narrative

AN EVENT REGARDING INFECTION INVOLVING A TIBIAL COMP KIN HINGE KNEE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW. THERE HAS BEEN NO OTHER EVENTS FOR THE REPORTED LOT OR STERILE LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT MRS DISTAL FEMUR WITH ALL POLY TIBIA WAS REMOVED DUE TO INFECTION.

Additional Manufacturer Narrative

ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 2481-8-010, LOT EUNHA, DESCRIPTION: MRS FEM ROT HINGE LFT 65MM BOD; CAT 6495-6-050, LOT LBHXA, DESCRIPTION: GMRS EXTENSION PIECE 50MM; CAT 6495-6-030, LOT S74JK, DESCRIPTION: GMRS EXTENSION PIECE 30MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED. PRODUCT NOT RETURNED TO MANUFACTURER.