KINMTC ROT HINGE SHRT TIB BEAR

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD SWELLING OF THE RIGHT KNEE. PATIENT HAS KRH HINGE. UPON EXPLORATION IT WAS DISCOVERED THAT THE POST GOING INTO THE BASEPLATE WAS FRACTURED. THE SURGEON REPLACED BUSHINGS, POLY, ROTATING COMPONENT, AXLE, AND BUMPER.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. PATIENT RETAINED DEVICE.

Additional Manufacturer Narrative

MANUFACTURING DATE AND EXPIRATION DATE CORRECTED. AN EVENT REGARDING A FRACTURE INVOLVING A KRH TIBIAL BEARING COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL NOT PERFORMED AS INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. THE CLINICAL CONSULTANT COMMENTED THAT IT IS NOT POSSIBLE TO ESTABLISH A ROOT CAUSE OF FAILURE BASED UPON THE CURRENT INFORMATION. DEVICE HISTORY REVIEW. ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD SWELLING OF THE RIGHT KNEE. PATIENT HAS KRH HINGE. UPON EXPLORATION IT WAS DISCOVERED THAT THE POST GOING INTO THE BASEPLATE WAS FRACTURED. THE SURGEON REPLACED BUSHINGS, POLY, ROTATING COMPONENT, AXLE, AND BUMPER.