BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK II CEMENTED REVERSIBLE SHOULDER

    MDR report key: 8666401 · Received June 4, 2019

    Report

    Report Number
    3014128390-2019-00013
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    April 19, 2019
    Report Date
    May 30, 2019
    Manufacturer
    FX SOLUTIONS
    Product Code
    KWS
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE EVENT WAS A REVISION SURGERY PERFORMED APPROXIMATELY 10 MONTHS AFTER THE PRIMARY SURGERY BECAUSE THE PATIENT KEPT DISLOCATING. THE SURGEON EXPLANTED THE 135/145 HUMERAL CUP 36/+9 (REF 313-0709). THE SURGEON THEN IMPLANTED A NEW STANDARD 36/+9 HUMERAL CUP (REF 103-0809) AS WELL AS A 135/145 REVERSED ADAPTER (REF 112-0100) TO ADD AN ADDITIONAL 9MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460325 HUMELOCK II CEMENTED REVERSIBLE SHOULDER CEMENTED SHOULDER PROSTHESIS KWS FX SOLUTIONS K1747

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R