BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK II

    MDR report key: 12679669 · Received October 22, 2021

    Report

    Report Number
    3009532798-2021-00152
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    September 6, 2021
    Report Date
    October 18, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    PMA / PMN Number
    K130759
    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

    PATIENT REVISED FOR POSTOP FRACTURE ON (B)(6) 2021. APPROXIMATELY 2 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED CENTERED HEAD, DOUBLE TAPER AND HUMELOCK II STEM SIZE 11. FOR THE REPLACED PRODUCT WAS NOT FX SOLUTIONS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583495 HUMELOCK II PROSTESIS SHOULDER HSD FX SOLUTIONS N1812

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization