BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KUDO ELBOW

    MDR report key: 6372016 · Received March 2, 2017

    Report

    Report Number
    3002806535-2017-00097
    Event Type
    Injury
    Date Received
    March 2, 2017
    Report Date
    March 1, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDB
    PMA / PMN Number
    PK972691
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT ¿ NI. DEVICE CODE ¿ NI. EXPIRATION DATE ¿ NI. DATE IMPLANTED ¿ NI. DATE EXPLANTED ¿ NI. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY JETSKE VIVEEN, ANTE PRKIC, KOEN L.M. KOENRAADT, IZAÄK F. KODDE, BERTRAM THE, DENISE EYGENDAAL. MANUFACTURE DATE ¿ NI. PMA 510(K): THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K972691.

    Description of Event or Problem · 1

    JOURNAL ARTICLE, "CLINICAL AND RADIOGRAPHIC OUTCOME OF REVISION SURGERY OF TOTAL ELBOW PROSTHESIS: MIDTERM RESULTS IN 19 CASES" HAS REPORTED 15 REVISION PROCEDURES THAT TOOK PLACE WHERE TOTAL ELBOW PROSTHESIS WERE REMOVED DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154685 UNKNOWN KUDO ELBOW PROSTHESIS, ELBOW JDB BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R