BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD HUMERAL CUP, HUMELOCK REVERSED

    MDR report key: 8666534 · Received June 4, 2019

    Report

    Report Number
    3014128390-2019-00008
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 30, 2019
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K162455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY WAS DUE TO DISLOCATION-THE PATIENT ROLLED OVER IN BED AND POPPED OUT GLENOSPHERE. SURGEON PUT IN THICKER HUMERAL BEARING DURING REVISION SURGERY. THE ORIGINAL HUMERAL CUP HAD A +9 LINER, AND THE SURGEON REPLACED THAT WITH A +6 CUP AND A +9 SPACER (FOR A TOTAL OF +15). SECOND REVISION SURGERY WAS PERFORMED ON APRIL 15, 2019. THE HUMERAL CUP AND SPACER WERE BOTH REPLACED AGAIN, THIS TIME WITH A +9 CUP AND A +9 LINER. THE EXPLANTED CUP WAS A 40/+6 HUMERAL CUP, REF 104-0806. THE EXPLANTED SPACER WAS A +9MM HUMERAL SPACER, REF 103-0007. THE NEW IMPLANTED HUMERAL CUP IS A 40/+9 HUMERAL CUP, REF 104-0809. THE NEW IMPLANTED SPACER IS A +9MM SPACER, REF 103-0007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459140 STANDARD HUMERAL CUP, HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS K1964

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R