BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 6202235 · Received December 23, 2016

    Report

    Report Number
    1226188-2016-00110
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    December 7, 2016
    Report Date
    December 8, 2016
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) 2011. THE REVISION SURGERY OCCURRED DUE TO TIBIAL SUBSIDENCE. DURING THIS REVISION, THE 3+ FEMORAL COMPONENT, THE SIZE 2 TIBIAL BASEPLATE, THE 3 X 12MM TIBIAL INSERT AND THE RETAINING BOLT, WERE REVISED TO NON-OMNI PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852371 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNILIFE SCIENCE, INC. 7918

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R