BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 24950301 · Received April 22, 2026

    Report

    Report Number
    3008021110-2026-00183
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 20, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390270823
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION RECORDS HAS BEEN PERFORMED AND DID NOT HIGHLIGHT ANY ANOMALY NOR NON-CONFORMITY ON INVOLVED COMPONENTS. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO GLENOID BONE LOSS AND STEM LOOSENING. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025. DURING ORIGINAL SURGERY FOLLOWING HUMERAL COMPONENTS WERE IMPLANTED: FINNED STEM DIA. 19 MM L. 80MM (PN: 1304.15.190, LOT: 2513645, STER. 2500096). 140° HUMERAL BODY REVERSE (PN: 1352.15.011, LOT: 2513035, STER. 2500105). EXTENSION FOR HUMERAL REVERSE BODY (PN: 1352.15.001, LOT: 2430343, STER. 2400276). SMR REVERSE LINER +3MM (PN: 1360.50.815, LOT: 21AT277, STER. 2200049). IN COMBINATION WITH GLENOID COMPONENTS FROM ANOTHER MANUFACTURER. DURING REVISION THE SURGEON EXPLANTED THE WHOLE ASSEMBLY, BOTH GLENOID AND HUMERAL COMPONENTS, THAT WERE REPLACED WITH GLENOID FROM OTHER MANUFACTURED AND SAME HUMERAL COMPONENTS WITH THE EXCEPTION OF A THICKER FINNED STEM AND A THICKER LINER, BELOW DETAILED: FINNED STEM DIA. 20 MM L. 80MM (PN: 1304.15.200). SMR REVERSE LINER +6MM (PN: 1360.50.820). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1961. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411508 SMR SHOULDER SYSTEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM HSD LIMACORPORATE S.P.A. 1304.15.190 2513645 08033390270823

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention