BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHELL INSERTER W/O ROTATION CONTROL

    MDR report key: 1733750 · Received June 16, 2010

    Report

    Report Number
    1226188-2010-00010
    Event Type
    Malfunction
    Date Received
    June 16, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 20, 2010
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREADED TIP CRACKED THEN PROPAGATED ACROSS THE THREADS SHEARING A SMALL SECTION OF THE TIP OFF COMPLETELY. PROBABLE CAUSE IS THAT THE IMPACTOR WAS NOT PROPERLY THREADED ON THE ACETABULAR CUP. THE SURGICAL TECHNIQUE STATES THE FOLLOWING: "THREAD THE DESIRED CUP COMPONENT ONTO THE CUP DRIVER. ENSURE THAT THE DRIVER IS FULLY SEATED TO AVOID DAMAGING THE THREADS." WHEN THE IMPACTOR IS NOT PROPERLY THREADED INTO THE SHELL THE IMPACTION LOAD IS ON THE THREADS AND NOT ON THE IMPACT PAN AS DESIGNED.

    Description of Event or Problem · 1

    IMPACTOR BROKE DURING CUP IMPACTION, CAUSED A DELAY IN SURGERY BY APPROX 20 MINUTES. OTHER THAN THE DELAY IN SURGERY THERE WAS NO IMPACT ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHELL INSERTER W/O ROTATION CONTROL INSERTER LXH OMNI LIFE SCIENCE, INC. C0408

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention