BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX POROUS DOVETAIL TIBIAL TRAY

    MDR report key: 1695766 · Received May 18, 2010

    Report

    Report Number
    1226188-2010-00008
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 21, 2010
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    MBH
    PMA / PMN Number
    K080842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON THE RIGHT KNEE. THERE WAS NO BONE GROWTH INTO THE TIBIAL POROUS COATED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX POROUS DOVETAIL TIBIAL TRAY TIBIAL TRAY COMPONENT OF THA MBH OMNI LIFE SCIENCE, INC. 3474

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention