BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAVIGATION SW KNEE ESSENTIAL 2.1.1. ZIMMER

    MDR report key: 1471046 · Received September 11, 2009

    Report

    Report Number
    8043933-2009-00007
    Event Type
    Other
    Date Received
    September 11, 2009
    Report Date
    August 18, 2009
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K073615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE CLINICAL EFFECT REPORTED TO BRAINLAB BY THIS OR ANY OTHER HOSPITAL. THERE IS A SYSTEMATIC PROBLEM AFFECTING THE BRAINLAB SOFTWARE KNEE WHICH COULD LEAD TO A LESS THAN OPTIMAL IMPLANTATION OF THE ZIMMER INNEX KNEE IMPLANT. CORRECTIVE AND PREVENTIVE ACTIONS: EXISTING POTENTIALLY AFFECTED CUSTOMERS RECEIVE A PRODUCT NOTIFICATION INFO. POTENTIALLY AFFECTED CUSTOMERS WILL RECEIVE A DATABASE UPDATE TO ENSURE CORRECT IMPLEMENTATION FOR ZIMMER INNEX IMPLANTS.

    Description of Event or Problem · 1

    ON (B)(6), 2009 BRAINLAB AG BECAME AWARE OF A POTENTIAL SYSTEMATIC PROBLEM AFFECTING THE BRAINLAB SOFTWARE KNEE. INVESTIGATION HAS SHOWN THAT INCORRECT ZIMMER IMPLANT DATA IN BRAINLAB SOFTWARE KNEE LEADS TO INCORRECT INFO FOR ZIMMER INNEX IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATION SW KNEE ESSENTIAL 2.1.1. ZIMMER IMAGE GUIDED SURGERY SYSTEM HAW BRAINLAB AG 21100-01C NA

    Patients

    Seq Age Sex Outcome Treatment
    1