BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 2428442 · Received December 21, 2011

    Report

    Report Number
    1226188-2011-00013
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    November 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    JWH
    PMA / PMN Number
    K073602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE APEX KNEE CR FEMUR, CEMENTLESS APPEARED LOOSE ON THE PT'S X-RAY. THE FEMORAL COMPONENT WAS REMOVED DURING A REVISION SURGERY AND REPLACED WITH AN APEX KNEE CR FEMUR, CEMENTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention