BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 9774074 · Received March 2, 2020

    Report

    Report Number
    3009532798-2020-00106
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    February 14, 2020
    Report Date
    February 27, 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 DUE TO A DISMANTLING OCCURRED (B)(6) 2020. 36 GLENOSPHERE AND 36/+6 HUMERAL CUP WERE REMOVED AND AFTER A THOROUGH CLEANING REPLACED BY OTHER 36 GLENOSPHERE AND 36/+6 HUMERAL CUP. THE REASON OF THE DISMANTLING REMAIN UNKNOWN (THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, THE DHR IS COMPLIANT, NO OTHER EVENT ON THIS BATCH AND NO FURTHER INFORMATION AVAILABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238578 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS N1525

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R