BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 19914506 · Received August 5, 2024

    Report

    Report Number
    1644408-2024-01217
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 5, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    UDI-DI
    00888912144544
    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 PREVIOUS REPORT NUMBER 1644408-2023-00204; 509-00-036, 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
    1771117 DJO SURGICAL RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXE-PLUS PHX ENCORE MEDICAL L.P. 378P1413 00888912144544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 506-03-114 LOT: 831C2017| 506-03-118 LOT: 832C1865| 506-03-130 LOT: 835C1870| 506-03-134 LOT: 836C1358| 508-32-204 LOT: 769P2236| 508-36-101 LOT: 869C3356| 510-08-000 LOT: 142G1408| 530-12-048 LOT: 1486A1106