BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 24322374 · Received February 12, 2026

    Report

    Report Number
    3008021110-2026-00063
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    December 9, 2025
    Report Date
    February 12, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWS
    UDI-DI
    08033390272797
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING RECORD FOR BATCHES OF EXPLANTED COMPONENTS DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALY OR NON-CONFORMITY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE.THE MANUFACTURER WILL PROVIDE A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO GLENOID FAILURE. DURING REVISION, THE FOLLOWING PRE-EXISTING SHOULDER PROSTHESIS COMPONENTS WERE REMOVED: SMR GLENOID BASEPLATE SMALL-R (PN 1375.15.605, LOT 2511769, STERILIZATION (B)(4)), SMR GLENOID PEG TT SMALL-R #M (PN 1375.14.652, LOT 2514981, STERILIZATION (B)(4)), SMR CONNECTOR SMALL R (PN 1374.15.305, LOT 2509762, STERILIZATION (B)(4)), SMR GLENOSPHERE Ø 36MM (PN 1374.09.111, LOT 2512612, STERILIZATION (B)(4)), SMR REVERSE LINER + 6 MM (PN 1360.50.820, LOT 24AT5NV, STERILIZATION (B)(4)). SURGEON CONVERTED THE REMOVED REVERSE ASSEMBLY TO AN ANATOMIC CONFIGURATION IMPLANTING AN ADAPTOR 36MM FOR REVERSE BODY (PN 1352.15.200) AND A CTA HEAD DIA46MM (PN 1323.09.460). THE SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY IS UNKNOWN. THE PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1943. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381693 SMR SHOULDER SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R KWS LIMACORPORATE S.P.A 1375.15.605 2511769 08033390272797

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention