BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION STEM COLLAR COUNTERBORE

    MDR report key: 1202408 · Received October 16, 2008

    Report

    Report Number
    1822565-2008-00699
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FRACTURE OF THE GUIDE PORTION AT THE MOST PROXIMAL NOTCH MAY HAVE OCCURRED, DUE TO A "LEVERING UP" PERPENDICULAR TO THE AXIS OF THE HUMERUS, WHILE REMOVING THE COUNTERBORE FROM THE HUMERAL CANAL, THEREBY CAUSING AN EXCESSIVE BENDING MOMENT ON THE THIN SECTION. THIS MAY THEN HAVE ALLOWED THE REAMER PORTION TO SEPARATE FROM THE BODY PORTION. THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: AS RETURNED, THE COUNTERBORE STEM IS FRACTURED AT THE DISTAL RETAINING TIP. ALL PARTS WERE RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THERE IS NO INDICATION THAT DESIGN OR MANUFACTURE CONTRIBUTED TO THIS OUTCOME. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE BROKE WHILE THE SURGEON WAS REAMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION STEM COLLAR COUNTERBORE SHOULDER INSTRUMENT LXH ZIMMER, INC. NA 60801435

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK