BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR INTERLOK FEMORAL RIGHT 57.5

    MDR report key: 2093247 · Received May 18, 2011

    Report

    Report Number
    1825034-2011-00394
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY." THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) , 2011 DUE TO ASCEPTIC LOOSENING. THE FEMORAL AND TIBIAL COMPONENTS WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD CR INTERLOK FEMORAL RIGHT 57.5 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 917340

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R