BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL HIP STRAIGHT SHELL INSERTER

    MDR report key: 2241441 · Received August 18, 2011

    Report

    Report Number
    1822565-2011-01897
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE. THIS INSTRUMENT HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 1 YEAR AND 2 MONTHS. THE FREQUENCY OF USE OF THIS INSTRUMENT IS NOT KNOWN. ONE OR A COMBINATION OF THE FOLLOWING FACTORS MAY HAVE CONTRIBUTED TO THE EXPERIENCE OBSERVED. USE OF THIS DEVICE W/O AN ADAPTER MAY HAVE LED TO HIGH STRESS ON THE BOLT THREADS; INSUFFICIENT THREAD ENGAGEMENT DURING IMPACTION MAY HAVE LED TO HIGH STRESS ON THE BOLT THREADS; OFF-AXIS IMPACTION OF THE DEVICE COUPLED WITH SUFFICIENT OR INSUFFICIENT THREAD ENGAGEMENT MAY HAVE LED TO HIGH STRESS ON THE BOLT THREADS. GIVEN THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE EVENT OBSERVED CANNOT BE DETERMINED WITH CERTAINTY. AS RETURNED, THERE ARE MANY STRIKE MARKS ON THE IMPACTION SURFACE ALONG WITH THE DAMAGE MARKS ON THE CYLINDRICAL SHAFT PORTION AND THE KNURLED SURFACE. SEM ANALYSIS IS PERFORMED FOR THE PART AND IT INDICATES THAT THE FRACTURE IS CAUSED BY BENDING OVERLOAD. AFTER REVIEWING THE DEVICE HISTORY RECORDS THEY WERE FOUND TO BE CONFORMING TO REQUIREMENTS AT THE TIME OF MANUFACTURE. THE DEVICE MEETS PRINT SPECIFICATIONS WHERE MEASURED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INSERTER THREADS FRACTURED OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL HIP STRAIGHT SHELL INSERTER LXH ZIMMER, INC. 61505542

    Patients

    Seq Age Sex Outcome Treatment
    1