BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMELOCK II

    MDR report key: 20484868 · Received October 18, 2024

    Report

    Report Number
    3014128390-2024-00057
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 18, 2024
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    HSD
    UDI-DI
    03701037300503
    PMA / PMN Number
    K123814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEFECT IN DEVICE PACKAGING LEAD TO LOSS OF STERILITY. CAPA: 2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    DURING SURGERY, 2 OF 48X19 OFFSET HEAD WAS OPENED AND IT WAS SEEN THAT THE SIDE WALL OF THE PLASTIC TRAY WAS DAMAGED, BREAKING THE PRIMARY STERILE BARRIER. THE WHITE OUTER BOX WAS UNDAMAGED AND DID NOT SHOW ANY SIGNS OF THE CONTAINED DEFECT. APPROXIMATELY 10 MINUTES OF SURGICAL DELAY NOTED. CAPA: 2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076148 HUMELOCK II SHOULDER PROSTHESIS HSD FX SHOULDER SOLUTIONS DALLAS S1182 03701037300503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PART: 116-4800 LOT: N2201.