BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 6126022 · Received November 23, 2016

    Report

    Report Number
    1226188-2016-00096
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 26, 2016
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 A LOOSE PATELLA. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL INSERT, RETAINING BOLT AND PATELLA WERE REVISED. THE ORIGINAL 3 X 10MM INSERT WAS REVISED TO A 3 X 14MM INSERT, AND THE 32MM X 8MM PATELLA WAS REVISED TO A 35MM X 8MM PATELLA. THE RETAINING BOLT WAS REVISED TO A NEW COMPONENT OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777423 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC. 15738

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R