BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 4987888 · Received August 5, 2015

    Report

    Report Number
    1226188-2015-00056
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 18, 2015
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 AND STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2015. THE ORIGINAL SURGERY WAS DATED (B)(6) 2011. THE REVISION SURGERY WAS DUE TO THE KNEE JOINT NOT BEING ABLE TO REACH FULL EXTENSION. IN THE REVISION, THE 2X 12MM TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS. THE INSERT WAS REVISED TO A 2X 10MM INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516188 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC. 7019

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R