BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMELOCK REVERSED

    MDR report key: 9738776 · Received February 21, 2020

    Report

    Report Number
    3009532798-2020-19536
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    September 30, 2019
    Report Date
    February 21, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K162455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN (B)(6)) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURED ON (B)(6) 2019 DUE TO INFECTION WITH HUMELOCK REVERSED SYSTEM. A 36/14 STEM CEMENTLESS AND 40MM HUMERAL CUP WERE EXPLANTED AND REPLACED BY 36/12 STEM CEMENTLESS AND 40MM HUMERAL CUP. PRIMARY SURGERY OCCURED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205742 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS L1147

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R