BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 21964952 · Received May 5, 2025

    Report

    Report Number
    1644408-2025-00577
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    UDI-DI
    00888912024648
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2018-00224; 508-00-432, S814 - STABILITY, POOR JOINT, 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 INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102379 DJO SURGICAL SOCKET, INSERT 32MM STD. RSP HUMERAL PHX ENCORE MEDICAL L.P. 855C1904 00888912024648

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention