BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING 10MM X 79/83MM

    MDR report key: 2173596 · Received July 23, 2011

    Report

    Report Number
    1825034-2011-00603
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 23, 2009
    Report Date
    June 24, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    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)(4), 2011.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2008 AND ALLEGES THAT A SUBSEQUENT REVISION TOTAL KNEE ARTHROPLASTY PROCEDURE WAS PERFORMED ON (B)(6), 2009 DUE TO LOOSENING AND CHRONIC PAIN. DETAILS REGARDING THE COMPONENTS IMPLANTED ON (B)(6), 2008 WERE CONFIRMED BY A REVIEW OF INVOICE HISTORY; HOWEVER, INVOICE HISTORY DID NOT REVEAL DETAILS REGARDING THE REVISION PROCEDURE REPORTED. NO FURTHER INFORMATION CONCERNING WHAT WAS REMOVED AND REPLACED DURING THE REVISION PROCEDURE HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM CR TIBIAL BEARING 10MM X 79/83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 253040

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R