BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 19834569 · Received July 25, 2024

    Report

    Report Number
    1644408-2024-01139
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LZO
    UDI-DI
    00888912076258
    PMA / PMN Number
    K932481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE D1, D2, D4, H2, H4, AND H11. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2021-00316; 400-04-360, S803 - DISLOCATION, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464582 DJO SURGICAL HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 36MM LZO ENCORE MEDICAL L.P. 883B1251 00888912076258
    484894 DJO SURGICAL HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 36MM LZO ENCORE MEDICAL L.P. 883B1251 00888912076258

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention 400-05-007 LOT: 888B1076.