BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR HEAD ASSEMBLY

    MDR report key: 3173195 · Received May 31, 2013

    Report

    Report Number
    3004153240-2013-00091
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CONFORMIS
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REUSABLE FEMORAL IMPACTOR HEAD BROKE AT THE POINT WHERE THE COMPONENT CONNECTS TO THE IMPACTOR HANDLE. INVESTIGATION OF THE AFFECTED LOT OF MATERIAL INDICATED THAT THERE WAS A SPECIFIED RADIUS MISSING AT THE BOTTOM OF THE CONNECTION POST WHERE THE FRACTURE OCCURRED. EVALUATION OF THE RETURNED DEVICE CONFIRMED THIS FINDING.

    Description of Event or Problem · 1

    THE REUSABLE FEMORAL IMPACTOR HEAD BROKE AT THE POINT WHERE THE COMPONENT CONNECTS TO THE IMPACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241712 FEMORAL IMPACTOR HEAD ASSEMBLY REUSABLE IMPACTOR COMPONENT LXH CONFORMIS L120701

    Patients

    Seq Age Sex Outcome Treatment
    1