BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM PS TIBIAL BEARING

    MDR report key: 1201143 · Received October 20, 2008

    Report

    Report Number
    1825034-2008-00274
    Event Type
    Injury
    Date Received
    October 20, 2008
    Report Date
    September 24, 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
    OH, 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. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THAT THE PITS ON CONDYLE SURFACE INDICATE THAT, THERE WERE THIRD BODY PARTICLES THAT BECAME ENTRAPPED, BETWEEN THE TIBIAL BEARING AND THE FEMORAL COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2007. REVISION PROCEDURE WAS PERFORMED APPROXIMATELY TWO (2) MONTHS AGO. THE TIBIAL BEARING WAS RETURNED TO BIOMET ORTHOPEDICS FOR EVALUATION, DUE TO PITTING ON THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM PS TIBIAL BEARING PROSTHESIS, KNEE COMPONENT JWH BIOMET INC. N/A 182490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R