BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION CUP, 10 HOLE, 18MM

    MDR report key: 23865591 · Received December 22, 2025

    Report

    Report Number
    2031009-2025-00028
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 22, 2025
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    UDI-DI
    00842188100734
    PMA / PMN Number
    K050681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SALES REP REPORTED ON 26NOV2025 THAT A FC10 HAD TO BE REMOVED FROM A PATIENT DUE TO A NON-UNION. AFTER THE DEVICE WAS REMOVED, IT WAS DISCOVERED THAT THE FC10 WAS CRACKED/BROKEN. THE DEVICE AND THE REPS' FIELD FEEDBACK FORM WAS MAILED TO TRIMED AND RECEIVED ON 11DEC2025 WHICH IS WHEN THE INFORMATION ABOUT THE RETURN WAS FORWARDED TO THE QUALITY DEPARTMENT. QUALITY FOLLOWED UP WITH THE REP ON 11DEC2025 WHICH THE REP PROVIDED ADDITIONAL INFORMATION ON 15DEC2025. THE REP STATED THAT THEY ARE NOT SURE WHEN THE DEVICE WAS ORIGINALLY IMPLANTED, HE ASSUMES THE DISCOMFORT WAS RELATED TO THE FACT THAT THIS WAS A NON-UNION, HE DOES NOT KNOW WHAT WAS USED TO REPLACE THE DEVICE AND HE DOES NOT KNOW WHAT CAUSED THE NON-UNION. PATIENT RELATED INFORMATION IS UNKNOWN. THE REMOVAL SURGERY WAS SUCCESSFUL BUT THERE WERE NO X-RAYS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564569 FUSION CUP, 10 HOLE, 18MM FC10 HRS TRIMED, INC. AX21003 00842188100734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown