BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 25278189 · Received May 26, 2026

    Report

    Report Number
    3008021110-2026-00222
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWT
    UDI-DI
    08033390001410
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY REVIEW OF MANUFACTURING AND STERILIZATION RECORDS DID NOT HIGHLIGHT ANY PRE-EXISTING NON-CONFORMITY RELEVANT TO THE ISSUE. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO ROTATOR CUFF FAILURE. PREVIOUS SURGERY OCCURRED ON (B)(6) 2021 FOR A TOTAL SHOULDER ARTHROPLASTY WITH SMR ANATOMIC COMPONENTS: GLENOID METAL BACK STD (PN 1375.21.010, LOT 2100627, STERILIZATION 2100093). LINER FOR METAL BACK STD (PN 1377.50.010, LOT 20AT3K4, STERILIZATION 2100083). FINNER STEM DIA20MM (PN 1304.15.200, LOT 1804199, STERILIZATION 1800137). FINNED HUMERAL BODY (PN 1350.15.110, LOT 2022509, STERILIZATION 2100045). ADAPTOR TAPER ECCENTRICAL (PN 1331.15.274, LOT 2016589, STERILIZATION 2100139). HUMERAL HEAD DIA50 (PPN 1322.09.500, LOT 1503172, STERILIZATION 2100045). DUE TO ROTATOR CUFF FAILURE, THE ORIGINAL IMPLANT HAS BEEN CONVERTED TO A REVERSE CONFIGURATION REMOVING THE ABOVE-MENTIONED HUMERAL HEAD, ADAPTOR TAPER AND LINER FOR METAL BACK AND REPLACING THEM WITH: CONNECTOR+ SCREW SMALL STD (PN 1374.15.310). GLENOSPHERE DIA36MM (PN 1374.09.111). REVERSE HUMERAL BODY (PN 1352.15.010). EXTENSION FOR REVERSE HUMERAL BODY (PN 1352.15.001). REVERSE LINER STANDARD (PN 1360.50.810). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31104 SMR SHOULDER HUMERAL HEADS (COCRMO) DIA.50MM KWT LIMACORPORATE S.P.A 1322.09.500 1503172 08033390001410

    Patients

    Seq Age Sex Outcome Treatment
    1