BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL HEAD TRAIL

    MDR report key: 24686680 · Received March 25, 2026

    Report

    Report Number
    MW5185765
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 16, 2026
    Report Date
    March 18, 2026
    Manufacturer
    CATALYST ORTHOSCIENCE INC.
    Product Code
    KWT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HUMERAL HEAD IMPLANT TRIAL POST BROKE AND RETAINED IN PATIENT'S PROXIMAL HUMERUS. RISK OF RETRIEVAL OUTWEIGHS BENEFIT. DISCLOSED TO PATIENT AND FAMILY BY SURGEON. TRIAL SIZE: H "INFERIOR PEG BROKE OFF IN PATIENT WHILE SURGEON WAS TRIALING SIZE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744615 HUMERAL HEAD TRAIL PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT CATALYST ORTHOSCIENCE INC. 1226-4060-008 12289003

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male