BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 21770685 · Received April 4, 2025

    Report

    Report Number
    3008021110-2025-00027
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 4, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    UDI-DI
    08033390002073
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE COMPONENTS INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PART CODE AND LOT NUMBER AS THE DEVICES REMOVED. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INFECTION. ALL THE FOLLOWING COMPONENTS WERE REMOVED: SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.140, LOT NUMBER 2211467, STERILIZATION (B)(4), SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2012985, STERILIZATION (B)(4), SMR REVERSE LINER +3MM D.40MM (PART CODE 1365.50.815, LOT NUMBER 23AT023, STERILIZATION (B)(4), SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT NUMBER 2321556, STERILIZATION (B)(4), SMR SMALL/STD CONNECTOR +2 (PART CODE 1374.15.322, LOT NUMBER 2213447, STERILIZATION (B)(4), SMR GLENOID PEG TT S/STD #M (PART CODE 1375.14.662, LOT NUMBER 1908192, STERILIZATION (B)(4), SMR GLENOID BASEPLATE STANDARD (PART CODE 1375.15.610, LOT NUMBER 1908455, STERILIZATION (B)(4), BONE SCREW Ø6,5 H.30MM (PART CODE 8420.15.030, LOT NUMBER 2327434, STERILIZATION (B)(4), BONE SCREW Ø6,5 H.35MM (PART CODE 8420.15.040, LOT NUMBER 2302588, STERILIZATION (B)(4). THE DEVICES REMOVED WERE REPLACED BY DIFFERENT COMPONENTS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A FEMALE, DATE OF BIRTH FEBRUARY (B)(6) 1961. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745460 SMR SHOULDER REVERSE HUMERAL BODY KWS LIMACORPORATE S.P.A. 1352.15.010 2012985 08033390002073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention