BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 10458642 · Received August 27, 2020

    Report

    Report Number
    3009532798-2020-00386
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    August 20, 2020
    Report Date
    August 27, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    PMA / PMN Number
    K111097
    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 CUFF TEAR OCCURRED (B)(6) 2020. 46 ECCENTRIC HEAD WAS REMOVED AND REPLACED BY 135/145 36/+3 HUMERAL CUP, 36 GLENOSPHERE, GLENOID BASEPLATE AND ASSOCIATED SCREWS. DATE OF PRIMARY SURGERY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923354 HUMERIS SHOULDER PROTHESIS HSD FX SOLUTIONS M1077

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R