BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22609501 · Received July 25, 2025

    Report

    Report Number
    3008021110-2025-00099
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 25, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390002035
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THIS EVENT, NO PRE-EXISTING ANOMALY WAS FOUND OUT. THE MANUFACTURER WILL SUBMIT THE FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO ROTATOR CUFF FAILURE. THE PATIENTS CUFF GAVE OUT AND WE HAD TO CONVERT FROM AN ANATOMIC TO A REVERSE CONSTRUCT. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 2221215, STERILIZATION (B)(4)). - LINER F.MET.BACK GLEN.STANDARD (PART CODE 1377.50.010, LOT NUMBER 21AT27C, STERILIZATION UNKNOWN). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6). THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009772 SMR SHOULDER FINNED HUMERAL BODIES WITH LOCKING SCREW HSD LIMACORPORATE S.P.A. 1350.15.110 2221215 08033390002035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention