BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 2459855 · Received February 13, 2012

    Report

    Report Number
    1226188-2012-00013
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K073602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON RIGHT KNEE DUE TO A LOOSE PRESS-FIT FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX KNEE SYSTEM CR FEMUR, CEMENTLESS, SZ3, RIGHT JWH OMNILIFE SCIENCE, INC. 4908

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention