BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 23510710 · Received November 10, 2025

    Report

    Report Number
    3008021110-2025-00144
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    September 24, 2025
    Report Date
    May 27, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390274272
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE SMR HUMERAL HEAD Ø50 MM, CODE 1322.09.500, LOT 1806259, STER. (B)(4), NO PRE-EXISTING ANOMALIES WERE DETECTED. AS STEM LOOSENING WAS MENTIONED BY THE COMPLAINT SOURCE, THE DEVICE HISTORY RECORDS OF THE SMR CEMENTLESS FINNED STEM Ø24, CODE 1304.15.240, LOT 1201838 STER. (B)(4) WERE ALSO CHECKED AND NO PRE-EXISTING ANOMALIES WERE DETECTED. A FINAL REPORT WILL BE SUBMITTED FOLLOWING THE INVESTIGATIONS.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO ROTATOR CUFF PATHOLOGY FOLLOWING AN SMR TOTAL SHOULDER ARTHOPLASTY. ACCORDING TO THE AVAILABLE INFORMATION, INTER-OPERATIVELY THE TT PEG ON THE GLENOID SIDE WAS SOLID AND THE SURGEON WAS ABLE TO CONVERT TO A REVISION TT BASEPLATE TO ACCOMMODATE A GLENOSPHERE. ON EVALUATION OF THE UNCEMENTED STEM IN SITU, THE SURGEON DETECTED SLIGHT MOVEMENT OF THE IMPLANT AND WAS CONCERNED ABOUT STABILITY. THE UNCEMENTED STEM (SMR CEMENTLESS FINNED STEM Ø24, CODE 1304.15.240, LOT 1201838 STER. (B)(4)) WAS THEN REMOVED AND A CEMENTED STEM WAS IMPLANTED. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. THIS EVENT OCCURRED IN CANADA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297672 SMR SYSTEM SMR SYSTEM - HUMERAL HEAD DIA. 50 MM KWT LIMACORPORATE S.P.A. 1322.09.500 1806259 08033390274272

    Patients

    Seq Age Sex Outcome Treatment
    1