BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMELOCK REVERSED

    MDR report key: 10927437 · Received December 1, 2020

    Report

    Report Number
    3009532798-2020-00607
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 20, 2020
    Report Date
    December 1, 2020
    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

    Additional Manufacturer Narrative · 1

    THIS MDR HAS ALREADY BEEN SUBMITTED TO FDA BY THE US IMPORTER WITH REPORT NUMBER 3014128390-2020-00083.

    Description of Event or Problem · 1

    PATIENT REVISED ON (B)(6) 2020 DUE TO INFECTION APPROXIMATELY 2 YEARS AFTER PRIMARY SURGERY. ALL COMPONENTS WERE EXPLANTED (24MM GLENOID BASEPLATE, 40MM CENTERED GLENOSPHERE WITH SCREW, HUMELOCK REVERSE 40/14 STEM, 40/+3 STANDARD HUMERAL CUP, 2 STANDARD SCREWS, AND 2 LOCKING SCREWS) AND AN ANTIBIOTIC SPACER WAS THEN IMPLANTED. NO MANUFACTURER PRODUCTS REMAIN IN THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391153 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS M0591

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R