BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR HEAD/TIBIAL IMPACTOR TIP

    MDR report key: 3112012 · Received May 1, 2013

    Report

    Report Number
    3004153240-2013-00073
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    CONFORMIS
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REUSABLE TIBIAL TRAY IMPACTOR TIP BROKE UPON IMPACTION AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. THE REUSABLE FEMORAL IMPACTOR HEAD BROKE UPON IMPACTION AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. SURGEON WAS ABLE TO PROCEED WITH PROCEDURE. NO KNOWN ADVERSE EFFECT TO PATIENT. PARTS WERE NOT RETURNED FOR EVALUATION. LOT NUMBERS ARE UNKNOWN. INVESTIGATION CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    THE REUSABLE TIBIAL TRAY IMPACTOR TIP BROKE UPON IMPACTION AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. THE REUSABLE FEMORAL IMPACTOR HEAD BROKE UPON IMPACTION AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. SURGEON WAS ABLE TO PROCEED WITH PROCEDURE. NO KNOWN ADVERSE EFFECT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190845 FEMORAL IMPACTOR HEAD/TIBIAL IMPACTOR TIP REUSABLE IMPACTOR COMPONENT LXH CONFORMIS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR