BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 22561980 · Received July 21, 2025

    Report

    Report Number
    1644408-2025-00996
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    UDI-DI
    00888912024754
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2024-00444; 508-32-204, S801 - DEVICE CRACKED/BROKE, S814 - STABILITY, POOR JOINT, REVISION SURGERY; SURGICAL - QUALITY COMPLAINTS. 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

    INSTRUMENT FAILURE: PATIENT WAS UNSTABLE AND THE CENTER SCREW OF THE BASEPLATE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766696 DJO SURGICAL BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM PHX ENCORE MEDICAL L.P. 866C3136 00888912024754

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention 506-03-114 LOT: 831C2221.| 506-03-114 LOT: 831C2306.| 508-32-101 LOT: 862C4008.| 509-02-032 LOT: 951W2163.