BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUMELOCK II REVERSED

    MDR report key: 13009689 · Received December 15, 2021

    Report

    Report Number
    3009532798-2021-00194
    Event Type
    Death
    Date Received
    December 15, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 6, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    UDI-DI
    03701037300237
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    PATIENT WAS REVISED ON (B)(6) 2021 DUE TO INFECTION. APPROXYMATELY 5 MONTHS AFTER THE FIRST SURGERY. SURGEON EXPLANTED CEMENTLESS GLENOID BASE, STEM TAV6 SIZE 10, HUMERAL CUP 135/145° 36+3, TWO STANDARD SCREW, TWO LOCKED SCREW, TWO CORTICAL SCREW AND CENTERED GLENOID. SURGEON IMPLANTED CEMENTLESS GLENOID BASE, STEM TAV6 SIZE 10, HUMERAL CUP 135/145° 36+3, TWO STANDARD SCREW, TWO LOCKED SCREW, TWO CORTICAL SCREW AND CENTERED GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907023 HUMELOCK II REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS 105-0024 P1303 03701037300237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization