BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 24-1410 PROMADE SHOULDER

    MDR report key: 21488035 · Received February 28, 2025

    Report

    Report Number
    3008021110-2025-00020
    Event Type
    Injury
    Date Received
    February 28, 2025
    Report Date
    February 26, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF COMPONENTS INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY WAS DISCOVERED ON THE ITEMS BELONGING TO THE SAME LOT NUMBERS. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    UPCOMING SHOULDER REVISION SURGERY DUE TO EARLY DISLOCATION DISCOVERED IN LATE (B)(6) 2025. THE SURGEON IS PLANNING ON SWAPPING OUT THE LINER AND ADDING A SPACER ON THE HUMERAL IMPLANT. THE SURGEON DOES NOT INTEND ON CHANGING ANYTHING OUT ON THE HUMERAL SIDE. THE FOLLOWING COMPONENTS WERE IMPLANTED ON THE GLENOID SIDE ON (B)(6) 2025: - SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT NUMBER 2432446, STERILIZATION (B)(4)). - (B)(6) GLENOID IMPLANT (PART CODE 9617.PE.022, LOT NUMBER 2431615, STERILIZATION (B)(4)). ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE SURGEON ENDED UP USING A THIRD PARTY'S HUMERAL STEM DURING THE SURGERY PERFORMED ON (B)(6) 2025. THE PATIENT IS A FEMALE, 78 YEARS OLD. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649334 CMD 24-1410 PROMADE SHOULDER CMD 24-1410 MONOBLOCK GLENOID PHX LIMACORPORATE S.P.A. 9617.PE.022 2431615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention