BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 19879414 · Received July 31, 2024

    Report

    Report Number
    1644408-2024-01158
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    FZX
    PMA / PMN Number
    K143242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO:1644408-2018-00553; 342-10-711, S808 - INFECTION, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187663 DJO SURGICAL EMPOWR 3D KNEETM INS, 11R 10MM, VE FZX ENCORE MEDICAL L.P. 081T1102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention