BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 25297977 · Received May 27, 2026

    Report

    Report Number
    3008021110-2026-00226
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 27, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWT
    UDI-DI
    08033390001373
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING AND STERILIZATION RECORDS DID NOT HIGHLIGHT ANY PRE-EXISTING NON-CONFORMITY THAT COULD HAVE CONTRIBUTED TO REPORTED 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 SHOULDER DISLOCATION. PREVIOUS SURGERY OCCURRED ON (B)(6) 2021, WHEN THE FOLLOWING ANATOMIC ASSEMBLY WAS IMPLANTED: FINNED STEM DIA16MM L80 (PN 1304.15.160), HUMERAL BODY TRAUMA SHORT (PN 1350.15.030, LOT 1508788, STERILIZATION 2100166), ADAPTOR TAPER NEUTRAL (PN 1330.15.270, LOT 2013121, STERILIZATION 2000263), HUMERAL HEAD DIA 42MM (PN 1322.09.420, LOR 1917287, STERILIZATION 1900460), GLENOID METAL BACK SMALL-R (PN 1375.21.005), LINER FOR METAL BACK SMALL-R (PN 1377.50.005, LOT 20AT0XS, STERILIZATION 2000235). AFTER PATIENT DISLOCATION, THE SURGEON DECIDED TO PERFORM A CONVERSION TO REVERSE CONFIGURATION FOR STABILITY. THE ABOVE MENTIONED HUMERAL BODY, ADAPTOR TAPER, HUMERAL HEAD AND LINER FOR METAL BACK WERE REMOVED AND REPLACED WITH HUMERAL BODY REVERSE (PN 1352.14.010), RETENTIVE LINER +6MM (PN 1361.50.820), CONNECTOR LATERALIZED+2MM SMALL-R (PN 1374.15.312) AND GLENOSPHERE DIA36MM (PN 1374.09.111). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1959. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605794 SMR SHOULDER HUMERAL HEADS (COCRMO) DIA.42MM KWT LIMACORPORATE S.P.A 1322.09.420 1917287 08033390001373

    Patients

    Seq Age Sex Outcome Treatment
    1