BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 23069687 · Received September 16, 2025

    Report

    Report Number
    1644408-2025-01329
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    KWS
    UDI-DI
    00888912144391
    PMA / PMN Number
    K112069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2023-00902; 508-32-204, S801 - DEVICE CRACKED/BROKE, 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

    REVISION SURGERY - DUE TO BASEPLATE CENTRAL SCREW BROKE OVER A YEAR OUT POST OPP. PREVIOUS DOCTOR DIDN'T GET ALL THE CARTILAGE OFF GLENOID SO BASEPLATE DIDN'T GROW IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636113 DJO SURGICAL RSP BASEPLATE, 30MM, W/P2 COATING KWS ENCORE MEDICAL L.P. 769P3431 00888912144391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R