BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OS KNEE UNIVERSAL

    MDR report key: 1581246 · Received January 15, 2010

    Report

    Report Number
    9617840-2010-00001
    Event Type
    Injury
    Date Received
    January 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 15, 2010
    Manufacturer
    ZIMMER CAS
    Product Code
    HAW
    PMA / PMN Number
    K060336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USE OF THE DEVICE IN FURTHER SURGERIES WAS STOPPED AND A REPLACEMENT TRACKING CAMERA SENT TO THE USER FACILITY. THE RETURN OF THE SUBJECT COMPONENT IS STILL PENDING TO ALLOW COMPLETING THE INVESTIGATION. THERE IS NO ADVERSE TREND OF SUCH AN OCCURRENCE.

    Description of Event or Problem · 1

    DURING A NAVIGATED TKR SURGERY, IT WAS REPORTED THAT THE SURGEON HAD TO REPEATEDLY ADJUST THE LOCATION OF THE TRACKING CAMERA ON THE NAVIGATION WORKSTATION TO REDUCE INTERFERENCE EFFECTS FROM THE OPERATING ROOM LIGHTS. THE EFFECTS INVOLVED TEMPORARY LOSS OF TRACKING DATA DEPENDING ON THE LOCATION OF THE CAMERA. THIS REPORTEDLY EXTENDED THE EXPECTED SURGERY TIME BY 30 MINUTES. THE SURGERY WAS OTHERWISE SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OS KNEE UNIVERSAL HAW (STEREOTAXIC INSTRUMENT) HAW ZIMMER CAS 201.045 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other