BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KUDO ELBOW

    MDR report key: 6579938 · Received May 19, 2017

    Report

    Report Number
    3002806535-2017-00391
    Event Type
    Injury
    Date Received
    May 19, 2017
    Report Date
    May 18, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K013042. HEIJINK, A. ET AL. "IDENTIFYING METALLOSIS AFTER KUDO TOTAL ELBOW ARTHROPLASTY IS CHALLENGING. A CLINICAL AND RADIOLOGICAL STUDY." ELBOW ARTHROPLASTY IN PERSPECTIVE. 7:125-140. REPORTED EVENTS WERE UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE ARTICLE AND NO PRODUCT WAS RETURNED. DHR AND COMPLAINT HISTORY COULD NOT BE REVIEWED DUE TO THE LACK OF INFORMATION RECEIVED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-00391, 3002806535-2017-00423, 3002806535-2017-00424 AND 3002806535-2017-00425.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO PATIENTS UNDERWENT ELBOW ARTHROPLASTY REVISIONS DUE TO METALLOSIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359762 UNKNOWN KUDO ELBOW PROSTHESIS, ELBOW JDC BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R