BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TT MB BASEPLATE

    MDR report key: 21824669 · Received April 11, 2025

    Report

    Report Number
    3008021110-2025-00036
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    February 2, 2025
    Report Date
    April 11, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO POOR BONE QUALITY. PATIENT HAD POOR GLENOID BONE CAUSING FAILURE OF METAL BACK MODULAR BASEPLATE. THE FOLLOWING COMPONENTS WERE REMOVED, AND THE BASEPLATE WAS REPLACED BY A DIFFERENT COMPONENT: SMR GLENOID PEG TT SMALL-R #M (PART CODE 1375.14.652, LOT NUMBER 2112913, STERILIZATION (B)(4). SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 2426231, STERILIZATION (B)(4). DATE OF PREVIOUS SURGERY IS UNKNOWN. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1959. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269620 TT MB BASEPLATE SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R KWS LIMACORPORATE S.P.A. 1375.15.605 2426231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention