BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 23511053 · Received November 10, 2025

    Report

    Report Number
    3008021110-2025-00142
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 10, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390204538
    PMA / PMN Number
    K212800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS REMOVED, NO PRE-EXISTING ANOMALIES HAVE BEEN FOUND IN THE ITEMS BELONGING TO THE SAME PRODUCT CODE AND LOT NUMBER AS THE DEVICES INVOLVED IN THE REVISION SURGERY HEREBY REPORTED. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INSTABILITY PERFORMED ON (B)(6) 2025. PATIENT UNDERWENT SURGERY FOR A REVERSE SHOULDER ON (B)(6) 2025, IN WHICH THE FOLLOWING COMPONENTS WERE IMPLANTED: - SHORT STEM PLUS #5 (PART CODE 1357.14.236, LOT NUMBER 2413552, STERILIZATION (B)(4)) - PRIMA REVERSE TRAY #SHORT (PART CODE 1367.15.010, LOT NUMBER 2434587, STERILIZATION (B)(4)) - PRIMA REV.INSERT #SHORT D.42MM (PART CODE 1367.54.300, LOT NUMBER 2122627, STERILIZATION (B)(4)) - SMR GLENOSPHERE Ø 42MM (PART CODE 1374.09.131, LOT NUMBER 2123235, STERILIZATION (B)(4)) - SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314, LOT NUMBER 2101336, STERILIZATION (B)(4)) - SMR METAL-BACK GLENOID SMALL R (PART CODE 1375.21.005, LOT NUMBER 2402374, STERILIZATION (B)(4)) THUMB TEST WAS DONE ON HUMERAL CUT SURFACE PRIOR TO IMPLANTATION OF PRIMA STEM. DUE TO THE SIZE OF THE PATIENT, THE SURGEON DETERMINED THE NECESSITY OF THIS IMPLANT TO ACHIEVE DESIRED MEDIALIZATION OF THE HUMERUS AND LATERALIZATION OF THE GLENOID COMPONENTS. THEREFORE, DURING THE REVISION HEREBY REPORTED, THE GLENOSPHERE AND THE LATERALIZED CONNECTOR WERE REMOVED AND REPLACED BY THE FOLLOWING COMPONENTS: - SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT NUMBER 2400301, STERILIZATION (B)(4)) - SMR SMALL-R CONNECTOR +2 (PART CODE 1374.15.312, LOT NUMBER 2410294, STERILIZATION (B)(4)) THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1963. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2581295 SMR SHOULDER SMR SHOULDER - GLENOSPHERE DIA. 42 MM PHX LIMACORPORATE S.P.A. 1374.09.131 2123235 08033390204538

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention