BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 19663542 · Received July 3, 2024

    Report

    Report Number
    3009532798-2024-00076
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 2, 2024
    Manufacturer
    FX SHOULDER SOLUTIONS
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE PATIENT WAS REVISED DUE TO SWELLING SUSPICIOUS FOR INFECTION ON (B)(6) 2024. THE IMPLANTATION DATE WAS UNKNOWN. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570530 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SHOULDER SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R