BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR HEAD ASSEMBLY

    MDR report key: 3112022 · Received May 1, 2013

    Report

    Report Number
    3004153240-2013-00075
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 2, 2013
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REUSABLE FEMORAL IMPACTOR HEAD BROKE AT THE POINT WHERE THE HEAD CONNECTS TO THE IMPACTOR HANDLE. SURGERY WAS COMPLETED SUCCESSFULLY. THE COMPONENT WAS NOT RETURNED FOR EVALUATION. LOT NUMBER IS UNKNOWN. INVESTIGATION CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    THE REUSABLE FEMORAL IMPACTOR HEAD BROKE AT THE POINT WHERE THE HEAD CONNECTS TO THE IMPACTOR HANDLE. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190961 FEMORAL IMPACTOR HEAD ASSEMBLY REUSABLE IMPACTOR COMPONENT HSX CONFORMIS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR