BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 70

    MDR report key: 3021427 · Received March 26, 2013

    Report

    Report Number
    0001825034-2013-00733
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    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. THIS REPORT IS NUMBER 1 OF 1 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-00733).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT BILATERAL VANGUARD TOTAL KNEE ARTHROPLASTY IN (B)(6) 2011. A SUBSEQUENT RIGHT REVISION WAS PERFORMED IN (B)(6) 2013 DUE TO ARTHROFIBROSIS. THE FEMORAL, TIBIAL PLATE AND BEARING COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124435 VANGUARD CR ILOK FEM-RT 70 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 773440

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R