BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 11885896 · Received May 26, 2021

    Report

    Report Number
    3009532798-2021-00069
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 26, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR HAS ALREADY BEEN SUBMITTED TO FDA BY THE US IMPORTER WITH REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    PATIENT REVISED FOR THIRD TIME ON (B)(6) 2021 DUE TO INFECTION, APPROXIMATELY 2 YEARS AFTER PRIMARY SURGERY. FIRST TWO REVISIONS OCCURRED IN 2019 AND HAVE BEEN PREVIOUSLY REPORTED. SURGEON EXPLANTED THE 40MM ECCENTRIC GLENOSPHERE WITH SCREW, 40/+3 STANDARD HUMERAL CUP, +9MM HUMERAL SPACER, AND 3 BASEPLATE LOCKING SCREWS. THEY THEN IMPLANTED A NEW 40MM ECCENTRIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787241 HUMELOCK REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS L1020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R