BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, KNEE

    MDR report key: 3230137 · Received July 16, 2013

    Report

    Report Number
    0001825034-2013-02716
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. SURGEON NOTED THE MEDIAL AUGMENT ON THE TIBIAL TRAY WAS LOOSE WHICH MAY HAVE RESULTED IN WEAR POTENTIALLY CAUSING THE DARK STAINED TISSUE WHICH WAS PRESENT. ANTIBIOTIC SPACERS WERE IMPLANTED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328808 PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R