BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM PS TIBIAL BEARING 12MM X 71/75MM

    MDR report key: 2001558 · Received February 25, 2011

    Report

    Report Number
    1825034-2011-00130
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K080528
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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: POSSIBLE ADVERSE EFFECT #2 - "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO POSSIBLE INFECTION AND LOOSENING OF TIBIA. THE TIBIAL TRAY AND TIBIAL BEARING WERE REMOVED AND REPLACED. ONLY THE TIBIAL BEARING WAS MANUFACTURED BY BIOMET ORTHOPEDICS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM PS TIBIAL BEARING 12MM X 71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 828890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R