BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMD 23-1428 PROMADE ELBOW

    MDR report key: 22078345 · Received May 23, 2025

    Report

    Report Number
    3008021110-2025-00059
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 23, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    UDI-DI
    08033390283397
    PMA / PMN Number
    N A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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

    INTRA-OPERATIVE ISSUE OCCURRED DURING THE SECOND STAGE OF ELBOW SURGERY. THE X-RAYS SHOWED THAT THE IMPLANTED COMPONENTS ARE DOING WELL. HOWEVER, WHEN ON (B)(6) 2025, THE SURGEON WENT TO IMPLANT THE HUMERAL BODY, HE FOUND THAT THE JOINT AXIS WAS FAR TOO PROXIMAL FOR FEASIBLE IMPLANTATION WHEN CONSIDERING THE SOFT TISSUES; IN HIS ESTIMATION, THE TOTAL HUMERAL ASSEMBLY LENGTH WOULD NEED TO BE APPROXIMATELY 10CM LONGER. THE CUSTOM-MADE DEVICE INVOLVED IN THIS EVENT IS THE FOLLOWING: CMD 23-1428 HUMERAL IMP. 30MM (PART CODE: 9617.P9.006, LOT NUMBER: 2421602, STERILIZATION: 2400186). RATHER THAN RISK THE STABILITY OF THE PREVIOUSLY IMPLANTED COMPONENTS, THE SURGEON CHOSE NOT TO PROCEED WITH IMPLANTING A HUMERAL BODY HIGHLIGHTING THAT WE WILL LIKELY NEED TO OPEN ANOTHER CUSTOM-MADE CASE TO ADDRESS THIS. THE FIRST STAGE WAS PERFORMED ON (B)(6) 2024. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515180 CMD 23-1428 PROMADE ELBOW CMD 23-1428 HUMERAL BODY - 30MM JDC LIMACORPORATE S.P.A. 9617.P9.006 2421602 08033390283397

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other