BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAVIGATION SOFTWARE 1.6.3 SMITH & NEPHEW

    MDR report key: 2170111 · Received June 20, 2011

    Report

    Report Number
    8043933-2011-00009
    Event Type
    Other
    Date Received
    June 20, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K021306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE IS NO INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE. ALTHOUGH THERE HAS BEEN NO PT INJURY REPORTED AT THIS HOSPITAL NOR REPORTED BY ANY OTHER HOSPITAL. A RISK TO THIS PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THIS ISOLATED CASE DUE TO THE LESS THAN OPTIMAL IMPLANTATION OF THE KNEE IMPLANT, AS LONGEVITY OF THE IMPLANT MAY POSSIBLY BE REDUCED. THERE IS NO INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE. THIS USER HAS EXPERIENCED WITH THE BRAINLAB DEVICE, AND USES THE BRAINLAB DEVICE REGULARLY SUCCESSFULLY FOR THE SAME KIND OF SURGERY. THERE ARE NO CORRECTIVE AND PREVENTIVE ACTIONS INTENDED BY BRAINLAB REGARDING THIS ISOLATED CASE AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    FOLLOWING TOTAL KNEE REPLACEMENT SURGERY SUPPORTED BY THE BRAINLAB NAVIGATION SYSTEM, THE SURGEON DETERMINED WITH A POST-OPERATIVE X-RAY THAT THE POSITION OF THE IMPLANTED SMITH & NEPHEW GENESIS II KNEE PROSTHESIS WAS NOT OPTIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATION SOFTWARE 1.6.3 SMITH & NEPHEW IMAGE GUIDED SURGERY SYSTEM, CAS HAW BRAINLAB AG 22086-05F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other