BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 4101718 · Received August 28, 2014

    Report

    Report Number
    1226188-2014-00053
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 14, 2014
    Manufacturer
    OMNLIFE SCIENCE INC.
    Product Code
    JWH
    PMA / PMN Number
    K102578
    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 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 PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2014. THE ORIGINAL SURGERY WAS DATED (B)(6) 2014. THE REVISION SURGERY WAS PERFORMED DUE TO THE KNEE JOINT HAVING DIFFICULTY GAINING FULL EXTENSION. THE SURGEON PERFORMED A POLY EXCHANGE OF THE TIBIAL INSERT AND RETAINING BOLT TO IMPLANTS WITH SMALLER THICKNESSES. THE TIBIAL INSERT WAS EXCHANGED FROM A 2 X 11MM TO A 2 X 10MM AND THE RETAINING BOLT WAS EXCHANGED FROM AN 11MM TO A 10MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526215 APEX KNEE JWH OMNLIFE SCIENCE INC. 13705

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R