BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK PRI TIB TRAY 71MM

    MDR report key: 4905536 · Received July 10, 2015

    Report

    Report Number
    0001825034-2015-02975
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 19, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO TIBIAL LOOSENING. THE TIBIAL TRAY AND TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450625 BIOMET ILOK PRI TIB TRAY 71MM PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 735790

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R