BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING

    MDR report key: 1143583 · Received September 3, 2008

    Report

    Report Number
    1825034-2008-00225
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 24, 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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY IN 2006. SUBSEQUENTLY, PATIENT WAS ADMITTED FOR RIGHT REVISION KNEE PROCEDURE IN 2008, SECONDARY TO PAIN IN JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM CR TIBIAL BEARING PROSTHESIS, KNEE COMPONENT JWH BIOMET INC. N/A 252020

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R