BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERIS

    MDR report key: 10338229 · Received July 29, 2020

    Report

    Report Number
    3009532798-2020-00271
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    January 30, 2020
    Report Date
    July 29, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REVISED ON (B)(6) 2020, APPROXIMATELY 7 WEEKS AFTER THE PRIMARY SURGERY ON DECEMBER 10 2019. DISTRIBUTOR WAS MADE AWARE OF THIS REVISION ON (B)(6) 2020. CAUSE OF REVISION IS UNAVAILABLE. SURGEON EXPLANTED 135/145 36/+3 STANDARD HUMERAL CUP AND IMPLANTED A NEW 135/145 36/+9 STANDARD HUMERAL CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805974 HUMERIS REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS 313-0703 M1480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R