BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 9799932 · Received March 6, 2020

    Report

    Report Number
    3009532798-2020-00048
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    January 23, 2020
    Report Date
    March 5, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K163669
    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

    A REVISION SURGERY FOR LOOSENING OCCURRED (B)(6) 2020. 36/+6 HUMERAL CUP WAS REMOVED AND REPLACED BY A 36/+6 HUMERAL CUP. PRIMARY SURGERY ON (B)(6) 2020. THE HUMERAL CUP WAS RETURNED TO US FOR ANALYSIS. THE ANALYSIS OF THE HUMERAL CUP AS WELL AS THE CONE ALLOW US TO CONCLUDE THAT THE DEVICE IS COMPLIANT TO THE SPECIFICATIONS. THE STUDY OF THE X-RAYS AFTER THE PRIMARY SURGERY AND BEFORE THE REVISION SURGERY SUGGEST THAT THE HUMERAL CUP WAS NOT POSITIONED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264173 HUMERIS REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS M3175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R