BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BKS HIGH FLEX

    MDR report key: 3835840 · Received May 13, 2014

    Report

    Report Number
    1722511-2014-00003
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    JWH
    PMA / PMN Number
    K123457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF ALL APPLICABLE DOCUMENTATION IN RELATION TO THE STERILIZATION OF THIS IMPLANT INDICATES ALL STERILIZATION PARAMETERS WERE WITHIN THE VALIDATED LIMITS. FURTHER, REVIEW OF ALL ENVIRONMENTAL MONITORING AND PERIODIC PRODUCT TESTING DID NOT REVEAL ANY CONDITION THAT WOULD HAVE INDICATED A THREAT TO STERILITY. EXACT ROOT CAUSE OF THE INFECTION IS NOT KNOWN.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN INFECTION IN THE JOINT SPACE APPROXIMATELY TWO WEEKS POST-OP FOLLOWING A PRIMARY TKA. THE SURGEON ELECTED TO ADDRESS THE INFECTION THROUGH RE-OPERATION TO THOROUGHLY CLEAN JOINT SPACE. THE TIBIAL INSERT WAS REMOVED AND REPLACED AS PART OF THE CLEANING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285438 BKS HIGH FLEX PS FEMORAL NONPOROUS RT, JWH/OIY JWH ORTHO DEVELOPMENT CORP. 165-1602 A124387

    Patients

    Seq Age Sex Outcome Treatment
    1 Other