BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 4212980 · Received October 24, 2014

    Report

    Report Number
    1226188-2014-00076
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 29, 2014
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K073602
    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 FOR THE EXPLANTED DEVICES REVEALED NO DEVIATION FROM PROCESS OF 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) 2013. THE REVISION SURGERY WAS A RESULT OF PATIENT PAIN. IN THE REVISION, THE TIBIAL LOCKING BOLT, THE TIBIAL INSERT AND THE FEMORAL COMPONENT WERE REVISED TO PS IMPLANTS AFTER EVALUATION OF THE SOFT TISSUE. THE INSERT WAS REVISED FROM A SIZE 2 X 10MM TO A SIZE 2 X 12MM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678258 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNLIFE SCIENCE, INC. 10714

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R