BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX BIOMET PRIMARY TIBIAL TRAY 75MM W/ LOCK BAR

    MDR report key: 2080633 · Received May 6, 2011

    Report

    Report Number
    1825034-2011-00348
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K080361
    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. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO A BONE CYST UNDER THE TIBIAL TRAY. THE 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 REGENEREX BIOMET PRIMARY TIBIAL TRAY 75MM W/ LOCK BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 376840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R