BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN BOX FEMORAL 70MM RIGHT INTERLOK

    MDR report key: 2120471 · Received June 10, 2011

    Report

    Report Number
    1825034-2011-00489
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    August 23, 2010
    Report Date
    May 31, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER TWO STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION". REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2010, DUE TO INFECTION. THE FEMORAL AND TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD PS OPEN BOX FEMORAL 70MM RIGHT INTERLOK PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 685860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R