BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERIS

    MDR report key: 9401646 · Received December 3, 2019

    Report

    Report Number
    3014128390-2019-00050
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 3, 2019
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    PMA / PMN Number
    K163669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMED SURGERY ON (B)(6) 2019, AND DISCOVERED THAT THE BROACH AND IMPLANT USED DID NOT CORRESPOND IN SIZE. THE SURGEON BROACHED UP TO A 14, BUT THE SIZE 14 HUMERUS IMPLANT WAS THE WRONG SIZE. THE SURGEON USED A SIZE 13 IMPLANT WITH THE SIZE 14 BROACH. THIS DID NOT CREATE A DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201578 HUMERIS SHOULDER PROSTHESIS HSD FX SOLUTIONS L2424

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization