BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 20103869 · Received August 29, 2024

    Report

    Report Number
    1644408-2024-01330
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    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 1644408-2019-00479; 509-00-032, 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
    1315508 DJO SURGICAL RSP STANDARD HUMERAL SOCKET INSERT, 32MM, HXE-PLUS PHX ENCORE MEDICAL L.P. 377P1706

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention