BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 19997452 · Received August 15, 2024

    Report

    Report Number
    1644408-2024-01243
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LZO
    UDI-DI
    00888912023306
    PMA / PMN Number
    K082844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO PREVIOUS REPORT NUMBER 1644408-2018-00572; 400-03-402, 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
    2350721 DJO SURGICAL HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM NEUTRAL LZO ENCORE MEDICAL L.P. 871B1462 00888912023306

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention 941-01-40I LOT: 606Z1078A