BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 20315627 · Received September 26, 2024

    Report

    Report Number
    1644408-2024-01464
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    KWS
    UDI-DI
    00190446259091
    PMA / PMN Number
    K172351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2022-01248; 533-10-108, 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
    1708729 DJO SURGICAL ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 6X108MM KWS ENCORE MEDICAL L.P. 923W1447 00190446259091

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention 520-46-216 LOT: 948U1230| 533-01-002 LOT: 010Y1100