BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 24-1029 PROMADE ELBOW

    MDR report key: 23081803 · Received September 18, 2025

    Report

    Report Number
    3008021110-2025-00115
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 18, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    UDI-DI
    08033390001212
    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 COMPONENTS INVOLVED IN THIS EVENT, NO PRE-EXISTING ANOMALY WAS FOUND OUT IN THE ITEMS BELONGING TO THE LOT NUMBER 2319345 AND STERILIZATION (B)(4), NOR IN THE ITEM BELONGING TO THE LOT NUMBER 2411772 AND STERILIZATION (B)(4). IT SHOULD BE NOTED THAT THE AXLES WITH PART CODE 1590.15.020, LOT 2227696, STERILIZATION (B)(4), WERE RECALLED FROM THE MARKET IN THE UNITED STATES WITH THE DEVICE REMOVAL 3008021110-11/06/24-001R (REPORTED TO THE FDA ON NOVEMBER 11TH, 2024). THIS DEVICE WAS IMPLANTED BEFORE THE MANUFACTURER BECAME AWARE OF THE PROBLEM THAT LED TO THE RECALL. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISASSOCIATION OF COMPONENTS. HUMERAL BODY WITH SAFETY SCREW DISENGAGED FROM MODULAR SPACER. THE PRODUCTS INVOLVED IN THIS EVENT WERE THE FOLLOWING: - SMR MODULAR AUGMENT H.40 MM (PART CODE 1314.15.040, LOT NUMBER 2319345, STERILIZATION (B)(4)). - CMD 24-1029 HUMERAL IMPLANT (PART CODE 9617.P9.007, LOT NUMBER 2411772, STERILIZATION (B)(4)). DURING THE REVISION SURGERY THE FOLLOWING COMPONENT PREVIOUSLY IMPLANTED: - TEMA AXLE LARGE (PART CODE 1590.15.020, LOT 2227696, STERILIZATION (B)(4)) WAS REMOVED AND REPLACED BY THE FOLLOWING ONE: - TEMA AXLE LARGE (PART CODE 1590.15.020, LOT 2504644, STERILIZATION (B)(4)) ALL OTHER COMPONENTS REMAINED IN SITU. DURING THE REVISION SURGERY, THE TIP OF REVISION/CONVERSION AXLE EXTRACTOR DRIVER BROKE INSIDE THE AXLE WHILE TRYING TO IMPLANT NEW ONE: THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00117. MOREOVER, A DRIVER FOR 2NM TORQUE LIMITER USED FOR FINAL IMPLANT ASSEMBLY BROKE IN IMPLANTING THE NEW AXLE: THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00121. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION ABOUT THE PATIENT. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731863 CMD 24-1029 PROMADE ELBOW SMR MODULAR SPACER H. 40MM JDC LIMACORPORATE S.P.A. 1314.15.040 2319345 08033390001212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention