BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 2211114 · Received August 5, 2011

    Report

    Report Number
    1226188-2011-00009
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Removal / Correction Number
    CAPA # 2011-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION IS BEING CARRIED OUT TO DETERMINE THE ROOT CAUSE OF THE BROWN STAIN ON THE FEMORAL TRIAL. A SUPPLEMENTARY MDR WILL BE SENT TO THE FDA ONCE THE INVESTIGATION HAS BEEN COMPLETED. NO PT WAS INVOLVED IN THIS EVENT. THE ISSUE WAS IDENTIFIED PRIOR TO USE IN A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    (B)(4). AFTER AUTOCLAVING THE INSTRUMENTS, IT WAS NOTICED THAT THE INNER SURFACE OF FEMORAL TRIAL WAS BROWNISH IN COLOR. THE FEMORAL TRIAL WAS RETURNED FOR EVAL. IT WAS CONFIRMED THAT THE FEMORAL TRIAL HAD A BROWN STAIN ON THE INNER SURFACE OF THE TRIAL. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX KNEE SYSTEM FEMORAL TRIAL JWH OMNILIFE SCIENCE, INC. KS-1420L MT1110

    Patients

    Seq Age Sex Outcome Treatment
    1