UNKNOWN METS PROXIMAL HUMERAL REPLACEMENT

Description of Event or Problem

THIS IS FOR IMPENDING REVISION DUE TO INFECTION. I REQUIRE FOR THE BODY OF HIS EXISTING METS PROXIMAL HUMERAL REPLACEMENT. HE IS INFECTED AND WE WISH TO UNDERTAKE A DAIR BUT BY LEAVING THE WELL FIXED CEMENTED HUMERAL STEM AND THE WELL FIXED GLENOID COMPONENT. THE BODY COMPONENTS THEREFORE NEED TO BE EXCHANGED. I BELIEVE I NEED 1) RIGHT BAYLEY WALKER HUMERAL COMPONENT WITH LINER WITHOUT REATTACHMENT, 2) 38MM SHAFT, 3) 22MM HUMERAL COLLAR COATED. HISTORY: EXCISION 18 YEARS AGO (PREVIOUS CHONDROSARCOMA). METS PROXIMAL HUMERAL REPLACEMENT UNDERTAKEN. DISLOCATED 10 YEARS AGO AND HAD PE EXCHANGE. 5 YEARS AGO CHRONIC INFECTION. NOW FOR A DEBRIDEMENT WITH IMPLANT RETENTION BUT WITH MODULAR EXCHANGE.

Additional Manufacturer Narrative

REPORTED EVENT: AN EVENT REGARDING INFECTION INVOLVING A METS PROXIMAL HUMERUS, BEARING COMPONENTS WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: INSUFFICIENT INFORMATION WAS PROVIDED TO SUPPORT A MEDICAL REVIEW. PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT IS PLANNED TO BE REVISED DUE TO INFECTION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.