BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDUO G2

    MDR report key: 3080751 · Received April 9, 2013

    Report

    Report Number
    3004153240-2013-00067
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 2013
    Manufacturer
    CONFORMIS
    Product Code
    NPJ
    PMA / PMN Number
    K093513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INCORRECT PATELLA WAS IMPLANTED DURING BICOMPARTMENTAL KNEE REPLACEMENT. THERE WAS NO ADVERSE IMPACT TO THE PT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT ALL PATELLA WERE PROPERLY IDENTIFIED AND ALL LABELING REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    INCORRECT PATELLA WAS IMPLANTED DURING BICOMPARTMENTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144898 IDUO G2 BICOMPARTMENTAL KNEE REPAIR SYSTEM NPJ CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR