BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KUDO ELBOW

    MDR report key: 6574342 · Received May 17, 2017

    Report

    Report Number
    3002806535-2017-00385
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    January 1, 2008
    Report Date
    September 19, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF EVENT: UNKNOWN DATE, 2008. IMPLANT DATE: UNKNOWN DATE, 2008. EXPLANT DATE: UNKNOWN DATE, 2008. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER 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: 3002806535-2017-00385 AND 0001825034-2017-03326.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL PATIENT UNDERWENT AN ELBOW REVISION DUE TO LOOSENING, LESS THAN ONE YEAR POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL PATIENT UNDERWENT AN ELBOW REVISION DUE TO LOOSENING AND CORTEX PENETRATION BY THE HUMERAL STEM, LESS THAN ONE YEAR POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354703 UNKNOWN KUDO ELBOW PROSTHESIS, ELBOW JDC BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R