BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 79MM

    MDR report key: 6222092 · Received January 4, 2017

    Report

    Report Number
    0009610576-2017-00002
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    November 18, 2016
    Report Date
    January 4, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 K945028. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - NI, MANUFACTURE DATE ¿ NI.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO THE LOCKING BAR BACKING OUT. THE LOCKING BAR WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4391 POLISHED FINNED TIB TRAY 79MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2016030696

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R