BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR FEMORAL

    MDR report key: 1141563 · Received September 3, 2008

    Report

    Report Number
    1825034-2008-00223
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT FILED SEPTEMBER 3, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY 2006. SUBSEQUENTLY, PATIENT WAS ADMITTED TO THE HOSPITAL FOR REVISION OF LEFT TOTAL KNEE, SECONDARY TO PAIN IN JOINT DUE TO OVERSIZED COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD CR FEMORAL PROSTHESIS, KNEE COMPONENT JWH BIOMET INC. N/A 829840

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R