BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMA ELBOW SYSTEM

    MDR report key: 21515482 · Received March 4, 2025

    Report

    Report Number
    3008021110-2025-00013
    Event Type
    Injury
    Date Received
    March 4, 2025
    Report Date
    March 4, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    PMA / PMN Number
    K181362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS, NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED ON THE (B)(4) ITEMS MANUFACTURED WITH THE LOT NUMBER 1906322. WE WILL SUBMIT THE FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    UPCOMING ELBOW REVISION SURGERY DUE TO LOOSENING. THE CUSTOM-MADE CASE (B)(4) CONCERNS REVISING A TEMA HUMERAL IMPLANT. THE IMPLANTS ARE STILL IN SITU: - HUMERAL STEM #H6 LEFT (PART NUMBER 1504.14.060, LOT NUMBER 1906322, STERILIZATION 2000051) - HUMERAL BODY SMALL LEFT+SCREW (PART NUMBER 1550.15.110, LOT NUMBER 2021999, STERILIZATION 2300003). - AXLE #SMALL (PART NUMBER 1590.15.010, LOT NUMBER 2303175, STERILIZATION 2300054). THE SURGEON REQUESTED A LONG HUMERAL STEM WITH BONE GROWTH DISTALLY AND CEMENTATION PROXIMALLY TO FIT A SMALL BEARING SURFACE. THE ULNAR IMPLANT (ULNAR BODY, PART CODE 1552.14.010, AND ULNAR LINER, PART CODE 1560.50.010) WILL NOT BE REVISED. THE STANDARD ULNAR AND HUMERAL COMPONENTS ABOVE MENTIONED WERE IMPLANTED ON (B)(6) 2024. THE PATIENT IS FEMALE, 78 YEARS OLD. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147725 TEMA ELBOW SYSTEM HUMERAL STEM H6 LEFT JDC LIMACORPORATE S.P.A. 1504.14.060 1906322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention