UNKNOWN RADIAL STEM

Additional Manufacturer Narrative

(B)(4). D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN STEM; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN SCREW; LOT#: UNKNOWN. G2: FOREIGN: POLAND. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. H6: COMPONENTS: MECHANICAL (G04) - STEM. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY ON AND UNKNOWN DATE DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. SOFT TISSUE METALLOSIS: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CAPITULUM HUMERI SURFACE DESTRUCTION: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AS IT IS UNKNOWN HOW THE CAPITULUM HUMERI SURFACE WAS DAMAGED. IT COULD HAVE BEEN DUE TO BONE LOSS, SECONDARY TO METALLOSIS, OR CAUSED BY ANOTHER UNREPORTED ISSUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.