BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 10760254 · Received October 30, 2020

    Report

    Report Number
    1226188-2020-00190
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 29, 2020
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    UDI-DI
    00841690100966
    PMA / PMN Number
    K060192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILIZATION DOCUMENTATION FOR THE DEVICES IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE SURGERY ON (B)(6) 2020. DURING THE SURGERY THE PATIENT WAS IMPLANTED WITH LEFT COMPONENTS INTO A RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231622 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC. KC-1145L 35759 00841690100966

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization