BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 23-1428 PROMADE ELBOW

    MDR report key: 23504969 · Received November 8, 2025

    Report

    Report Number
    3008021110-2025-00139
    Event Type
    Injury
    Date Received
    November 8, 2025
    Date of Event
    September 29, 2025
    Report Date
    November 8, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    PMA / PMN Number
    N A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE DEVICE INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT. THE MANUFACTURER WILL SEND THE FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    REVISION SURGERY OF CUSTOM-MADE DEVICE CMD 23-1428 PERFORMED ON (B)(6) 2025. DURING THE PREVIOUS SURGERY (PERFORMED ON (B)(6) 2025), THE HUMERAL BODY WAS DEEMED SHORT, AND THE SURGERY WAS NOT COMPLETED. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00059. AFTER THIS EVENT, NEW CUSTOM-MADE DEVICE WAS REQUESTED (CMD 25-1263), AND HUMERAL BODY/STEM WAS IMPLANTED CREATING MORE LENGTH. DURING THE REVISION SURGERY HEREBY REPORTED THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY THE NEW CUSTOM-MADE DEVICE CMD 25-1263: CMD 23-1428 HUMERAL IMPLANT (PART CODE: 9617.25.31R, LOT NUMBER: 2424319, STERILIZATION: 2400186). THE IMPLANT OF THE CMD 23-1428 WAS PERFORMED ON (B)(6) 2024. THE PATIENT IS A FEMALE. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849148 CMD 23-1428 PROMADE ELBOW CMD 23-1428 HUMERAL STEM JDC LIMACORPORATE S.P.A. 9617.25.31R 2424319

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention