BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 6157788 · Received December 9, 2016

    Report

    Report Number
    1226188-2016-00103
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 15, 2016
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT. 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

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY IN THE KNEE. DURING THE REVISION, THE TIBIAL INSERT, RETAINING BOLT, AND BASEPLATE WERE REVISED TO NEW COMPONENTS. THE ORIGINAL SIZE 2 X 11MM INSERT WAS REVISED TO A SIZE 2 X 14MM INSERT, THE SIZE 3 STANDARD BASEPLATE WAS REVISED TO A SIZE 3 MODULAR BASEPLATE, AND THE RETAINING BOLT WAS REVISED TO A NEW COMPONENT OF THE SAME SIZE. IN ADDITION, TWO TIBIAL AUGMENTS, TWO TIBIAL AUGMENT BOLTS AND A MODULAR STEM WAS ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812531 APEX KNEE SYSTEM PROSTHEIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNILIFE SCIENCE, INC. 16341

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R