BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 3874115 · Received May 29, 2014

    Report

    Report Number
    1226188-2014-00032
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    OMNLIFE SCIENCE
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT 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 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 PT WHO UNDERWENT THEIR SECOND KNEE REVISION SURGERY ON (B)(6)2014. THE FIRST REVISION SURGERY OCCURED (B)(6) 2013. THE REVISION SURGERY WS PERFORMED DUE TO POSSIBLE INFECTION. THE SURGEON PERFORMED A POLY EXCHANGE OF THE 3 X 12MM TIBIAL INSERT TO A 3 X 20MM TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317158 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE 4686

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R