BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOST STEM DISTRACTOR

    MDR report key: 2042230 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00590
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 12, 2010
    Report Date
    February 18, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE END TIPS OF THE STEM DISTRACTOR HAVE FRACTURED OFF; IT IS UNK WHETHER THIS WAS DUE TO THE ATTEMPT TO DISASSEMBLE THE FEMORAL SECTIONS OR OCCURRED AT AN EARLIER TIME. THE FRACTURED TIPS WERE NOT RETURNED. ALL OTHER COMPONENTS WERE RETURNED. STEM DISTRACTOR IS ESTIMATED TO HAVE BEEN IN THE FIELD FOR 5 YEARS, AND EXHIBITS SLIGHT WEAR AND CORROSION. THE TAPER DISTRACTORS HAD AN APPROXIMATE FIELD AGE OF 6 YEARS. BOTH TAPER DISTRACTORS' TORQUE PEGS EXHIBIT HEAVY GOUGES. ONE ALSO HAD A PARTIALLY DISASSEMBLED PIN. IT IS UNK HOW MANY TIMES EACH INSTRUMENT WAS USED. WITHOUT ADDITIONAL INFO, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE, IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE SEPARATION OF THE DISTAL CONDYLAR END, THESE DEVICES FAILED TO FUNCTION PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOST STEM DISTRACTOR HIP INSTRUMENT HAW ZIMMER, INC. 60281712

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR LOT #1604398 (QTY 2)| MOST TAPER DISTRACTOR: CATALOG #510000095