BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CONSTRAINED TIBIAL BEARING 10MM X 71/75MM

    MDR report key: 2183215 · Received July 28, 2011

    Report

    Report Number
    1825034-2011-00653
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K042757
    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE INFECTION, AND ALLERGIC REACTION." 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 INFECTION. ONLY THE TIBIAL BEARING WAS REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM CONSTRAINED TIBIAL BEARING 10MM X 71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 491320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R