HMRS ROT HINGE TIB ROT COMP
Received Mar 27, 2015 · Event occurred Mar 3, 2015
Report 0002249697-2015-00944 · MDR key 4638404
Device
Product problems
- Break
Patient
32 YR
- No Code Available
Narrative
Description of Event or Problem
DR. (B)(6) PERFORMED REVISION SURGERY AS PATIENT HAD A KOTZ ROTATING COMPONENT WHICH HAD BROKEN.
Additional Manufacturer Narrative
AN EVENT REGARDING COMPONENT FRACTURE INVOLVING AN HMRS TIBIAL ROTATING COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE POST OF THE TIBIAL ROTATING COMPONENT BROKE IN FATIGUE WITH THE FRACTURE PROGRESSING FROM THE POSTERIOR SIDE TO THE ANTERIOR SIDE. THE BASE METAL WAS FOUND TO BE A CO, CR, MO AND SI ALLOY CONSISTENT WITH ASTM F75 MATERIAL. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT PROVISION OF INFORMATION. FURTHER INFORMATION SUCH AS: X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION TO DETERMINE ROOT CAUSE.
Description of Event or Problem
DR. (B)(6) PERFORMED REVISION SURGERY AS PATIENT HAD A KOTZ ROTATING COMPONENT WHICH HAD BROKEN.
Additional Manufacturer Narrative
THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.