BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 20219332 · Received September 14, 2024

    Report

    Report Number
    1644408-2024-01406
    Event Type
    Injury
    Date Received
    September 14, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    UDI-DI
    00888912024693
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO PREVIOUS REPORT NUMBER 1644408-2023-00287; 508-01-432, 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
    1638773 DJO SURGICAL SOCKET, INSERT 32MM SEMI RSP HUMERAL PHX ENCORE MEDICAL L.P. 859C1026 00888912024693

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention 508-32-101 LOT: 862C1199