BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 5090650 · Received September 21, 2015

    Report

    Report Number
    1226188-2015-00070
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 21, 2015
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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) 2015. THE REVISION SURGERY WAS DUE TO INFECTION. IN THE REVISION, THE SIZE 6 X 10MM INSERT AND ACCOMPANYING RETAINING BOLT WERE REVISED AND REPLACED WITH NEW IMPLANTS OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622766 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC. 19312

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R