BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISH FINNED TIBIAL TRAY 79MM

    MDR report key: 5829887 · Received July 28, 2016

    Report

    Report Number
    0009610576-2016-00008
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    November 5, 2015
    Report Date
    July 4, 2016
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 3 YEARS POST-IMPLANTATION DUE TO ASEPTIC LOOSENING. PATIENT WAS OVERWEIGHT, WHICH WAS REPORTEDLY A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481292 POLISH FINNED TIBIAL TRAY 79MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2011110394

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R