BEUDAMED
    FDA Adverse Event Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 6086519 · Received November 8, 2016

    Report

    Report Number
    1226188-2016-00094
    Date Received
    November 8, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K102578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATES THE DEVICE REMAINS IMPLANTED, THEREFORE THE PRODUCT COULD NOT BE PHYSICALLY EVALUATED. REVIEW OF THE MANUFACTURING AND STERILIZATION DOCUMENTATION FOR THE IMPLANTED DEVICE REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT WITHIN ITS LABELED SHELF-LIFE.

    Description of Event or Problem · 1

    A PRODUCT WAS IMPLANTED PAST ITS LABELED EXPIRATION DATE ON 10/11/2016. AFTER IMPLANTING THE PRODUCT, THE SALES AGENT REALIZED THE PRODUCT WAS OUT OF DATE BY 11 DAYS (EXPIRED 9/2016). HE INFORMED THE OR STAFF, BUT THE DOCTOR CHOSE TO LEAVE THE IMPLANT IN THE PATIENT SINCE THE PATIENT WAS STITCHED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736428 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC. 9890

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other