BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TT MB BASEPLATE

    MDR report key: 24176099 · Received January 26, 2026

    Report

    Report Number
    3008021110-2026-00111
    Event Type
    Injury
    Date Received
    January 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWT
    UDI-DI
    08033390089562
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2011657, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 60 COMPONENTS MANUFACTURED WITH THE SAME LOT #. A FINAL MDR WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    TOTAL SHOULDER REVISION SURGERY OF AN SMR REVERSE IMPLANT WAS PERFORMED ON (B)(6) 2026, DUE TO ASEPTIC LOOSENING OF THE SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2011657 - STER.(B)(4). THE SURGEON EXPOSED THE SURGICAL SITE AND EXPLANTED THE LINER, HUMERAL BODY, STEM, GLENOSPHERE, AND BASEPLATE. THE BASEPLATE WAS THEN PREPARED FOR IMPLANTATION OF A NEW GLENOID COMPONENT USING A COMPETITOR IMPLANT SYSTEM. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION PROCEDURE: SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #2005901 - STER.(B)(4), SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #2006792 - STER.(B)(4), SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.190, LOT #2009886 - STER.(B)(4), SMR CONNECTOR SMALL-R (PRODUCT CODE 1374.15.305, LOT #2011115 - STER. (B)(4), SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT #2007768 - STER. (B)(4), SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2013168 - STER. (B)(4), SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2011657 - STER.2000258) BONE SCREW Ø6.5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2002713 - STER. (B)(4), BONE SCREW Ø6.5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2006404 - STER. (B)(4). THE PREVIOUS SHOULDER SURGERY WAS PERFORMED ON (B)(6) 2020. THE PATIENT IS A MALE, 77 YEARS OLD. NO ADDITIONAL CLINICAL INFORMATION IS AVAILABLE. THE EVENT OCCURRED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574025 TT MB BASEPLATE SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R KWT LIMACORPORATE S.P.A 08033390089562

    Patients

    Seq Age Sex Outcome Treatment
    1