BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRID PS TIB BRG 14X79/83

    MDR report key: 2840735 · Received November 20, 2012

    Report

    Report Number
    0001825034-2012-02461
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-01266, 02459 / 02461).

    Additional Manufacturer Narrative · 1

    REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 2012. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2012 DUE TO GOUT. THE BEARING WAS REMOVED AND REPLACED. A SECOND REVISION WAS PERFORMED (B)(6) 2012 DUE TO UNKNOWN REASONS. THE FEMORAL, TIBIAL TRAY AND BEARING WERE REMOVED AND REPLACED WITH STAGE ONE SPACER MOLDS.

    Description of Event or Problem · 1

    THE SECOND REPORTED REVISION PROCEDURE PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGRID PS TIB BRG 14X79/83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 968610

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R