BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERIS

    MDR report key: 9401588 · Received December 3, 2019

    Report

    Report Number
    3014128390-2019-00049
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    October 16, 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

    ON (B)(6) 2019, THE SURGEON REAMED TO A 9MM BROACH AND THE IMPLANT SAT PROUD. THE SURGEON REAMED TO A 10MM BROACH AND IMPLANTED A SIZE 9 HUMERIS STEM, WHICH DELAYED THE SURGERY BY ABOUT 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201647 HUMERIS SHOULDER PROSTHESIS HSD FX SOLUTIONS M3008

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization