BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 2885017 · Received December 18, 2012

    Report

    Report Number
    1226188-2012-00078
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 28, 2012
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT ORIGINAL KNEE WAS SUBLUXED. A POLYETHYLENE INSERT EXCHANGE WAS PERFORMED TO STABILIZE THE KNEE. ORIGINAL SURGERY PERFORMED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX KNEE SYSTEM DOVETAIL ULTRA TIBIAL INSERT JWH OMNLIFE SCIENCE, INC. 3622

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention