BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TM HUMERAL STEM INSERTER

    MDR report key: 2150573 · Received June 22, 2011

    Report

    Report Number
    1822565-2011-01481
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INSERTER HAD AN APPROXIMATE FIELD AGE OF FOUR AND A HALF YEARS AT THE TIME OF THE EVENT. IT IS POSSIBLE THAT THE TIP OF THE INSERTER FRACTURED DUE TO OFF AXIS IMPACTION BUT CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFO PROVIDED. AS RETURNED, THE TIP OF THE STEM INSERTER HAS FRACTURED. THE DEVICE SHOWS NUMEROUS DINGS AND GOUGES ON THE SHAFT UNDER THE STRIKE PLATE THAT COULD INDICATE OFF AXIS IMPACTION. THE DEVICE MEETS PRINT SPECIFICATIONS WHERE MEASURED, INCLUDING HARDNESS. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEG ON THE HUMERAL INSERTER BROKE WHILE IMPACTING THE PROVISIONAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TM HUMERAL STEM INSERTER LXH ZIMMER, INC. 60557933

    Patients

    Seq Age Sex Outcome Treatment
    1