BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOST STEM DISTRACTOR

    MDR report key: 2121980 · Received May 24, 2011

    Report

    Report Number
    1822565-2011-01232
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: BASED ON THE LOT NUMBER, THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 6 YEARS AND HAS BEEN USED AN UNKNOWN NUMBER OF TIMES DURING THE PERIOD. IT IS POSSIBLE THAT THE FRACTURE WAS CAUSED BY OFF-AXIS IMPACTION, AN APPLIED BENDING MOMENT, OR GENERAL FATIGUE BUT WITHOUT FURTHER INFORMATION AN EXACT CAUSE CANNOT BE DETERMINED. EVALUATION: AS RETURNED, ONE OF THE PRONGS ON THE DEVICE HAS FRACTURED AND WAS NOT RETURNED. HARDNESS OF THE DEVICE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. MANUFACTURING DOCUMENTATION INDICATES THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    WHILE TRYING TO SEPARATE TRIAL STEMS, THE DISTRACTOR WEDGE BROKE. THE BROKE PIECE COULD NOT BE FOUND, BUT IT WAS NOTED THE INSTRUMENT WAS NOT USED WITHIN CLOSE PROXIMITY TO THE PATIENT AND THE PATIENT WAS ALSO WASHED OUT THOROUGHLY PRIOR TO CLOSURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1