BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI CMNTLS TIB SZ C RM

    MDR report key: 5765911 · Received July 1, 2016

    Report

    Report Number
    3002806535-2016-00527
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    April 8, 2016
    Report Date
    June 3, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: INITIAL REPORTER - NAME NI. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) 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 PMA NUMBER P010014.

    Description of Event or Problem · 1

    PATIENT WAS REVISED ON THE RIGHT SIDE APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO PAIN AND FRACTURED TIBIA. ALL COMPONENTS WERE REMOVED AND REPLACED WITH TOTAL KNEE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420004 OXF UNI CMNTLS TIB SZ C RM PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 3481673

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R