BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIBIA BEARING 10X63/67

    MDR report key: 2846219 · Received November 27, 2012

    Report

    Report Number
    0001825034-2012-02490
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 1, 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
    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 OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO TIBIAL FRACTURE. THE SURGEON REPORTED THAT HE BELIEVED THERE WAS A SMALL FRACTURE IN THE TIBIA WHEN THE COMPONENTS WERE ORIGINALLY IMPLANTED. THE TIBIAL TRAY AND TIBIAL BEARING WERE REMOVED AND REPLACED. ONLY THE TIBIAL BEARING WAS MANUFACTURED BY BIOMET ORTHOPEDICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD CR TIBIA BEARING 10X63/67 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 454900

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R