BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING 12MM X 79/83MM

    MDR report key: 2250266 · Received September 15, 2011

    Report

    Report Number
    1825034-2011-00812
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    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. 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 IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-00811). 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. ALL COMPONENTS WERE REMOVED AND REPLACED. ONLY THE FEMORAL COMPONENT AND TIBIAL BEARING WERE 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 CR TIBIAL BEARING 12MM X 79/83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 323780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R