BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED SHOULDER

    MDR report key: 8771543 · Received July 9, 2019

    Report

    Report Number
    3014128390-2019-00018
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 9, 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

    A REVISION SURGERY OCCURRED ON (B)(6) 2019. ACCORDING TO THE SALES REP, THE PATIENT HAD THIN, WEAK BONE. INITIALLY, THE PATIENT WAS IMPLANTED WITH ANOTHER MANUFACTURER'S SYSTEM, WHICH WAS REVISED TO THE HUMELOCK REVERSED SYSTEM ON (B)(6) 2019 AFTER THE PATIENT SUFFERED A BONE FRACTURE. WHEN THE FRACTURE FAILED TO HEAL PROPERLY, ALL HUMERLOCK REVERSED SYSTEM COMPONENTS WERE EXPLANTED ON (B)(6) 2019 AND REPLACED WITH A DIFFERENT MANUFACTURER'S SYSTEM. NO FX SHOULDER COMPONENTS REMAIN IMPLANTED IN THE PATIENT. EXPLANTS INCLUDE HUMELOCK REVERSED STEM SIZE 12 (REF 317-3212), 40/+9 STANDARD HUMERAL CUP (REF 104-0809), 24MM GLENOID BASEPLATE (REF 105-0024), AND 40MM GLENOSPHERE (REF 105-4010).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566260 HUMELOCK REVERSED SHOULDER REVERSE SHOULDER PROSTHESIS PHX FX SOLUTIONS M1945

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R