BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMA ELBOW

    MDR report key: 21803469 · Received April 9, 2025

    Report

    Report Number
    3008021110-2025-00029
    Event Type
    Injury
    Date Received
    April 9, 2025
    Report Date
    April 9, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    PMA / PMN Number
    K222807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING AND STERILIZATION CHARTS, NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED IN THE ITEMS BELONGING TO THE SAME LOT NUMBERS AS THE THOSE INVOLVED IN THIS EVENT. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    ELBOW UPCOMING REVISION DUE TO DISLOCATION AND RECURRENT INFECTION. THE PATIENT HAD AN INGROWN HUMERAL COMPONENT AND A LOOSE ULNAR COMPONENT. ADDITIONALLY, HE HAS A FUNCTIONAL SPACER WITH THE ULNAR COMPONENT. THE PATIENT PREVIOUSLY SUSTAINED A RADIAL HEAD FRACTURE, WHICH WAS TREATED WITH A RADIAL HEAD REPLACEMENT THAT LATER BECAME INFECTED. FOLLOWING THIS, THE PATIENT DEVELOPED POST-INFECTIOUS ARTHRITIS. AS A RESULT, A TOTAL ELBOW ARTHROPLASTY WAS PERFORMED ON (B)(6), 2025, USING AN UNCEMENTED, UNLINKED TEMA ELBOW: - HUMERAL STEM #H8 RIGHT (PART CODE 1504.14.081, LOT NUMBER 2001336, STERILIZATION (B)(4)). - HUMERAL BODY LARGE RIGHT+SCREW (PART CODE 1550.15.121, LOT NUMBER 2421975, STERILIZATION (B)(4)). - ULNAR BODY LARGE RIGHT + SCREW (PART CODE 1552.14.021, LOT NUMBER 2309994, STERILIZATION (B)(4)). - ULNAR LINER - LARGE RIGHT (PART CODE 1560.50.021, LOT NUMBER 19AT1CS, STERILIZATION (B)(4)). - ULNAR STEM #U6.5 (PART CODE 1575.14.040, LOT NUMBER 2002823, STERILIZATION (B)(4)). THIS PROCEDURE WAS COMPLICATED BY DISLOCATION AND RECURRENT INFECTION. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1992. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417021 TEMA ELBOW HUMERAL BODY LARGE RIGHT JDC LIMACORPORATE S.P.A. 1550.15.121 2421975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention