BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOST STEM DISTRACTOR

    MDR report key: 2012322 · Received February 1, 2011

    Report

    Report Number
    1822565-2011-00157
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SINCE THE STEM DISTRACTOR IS A REUSABLE DEVICE, IT IS UNKNOWN HOW MANY TIMES THE DEVICE HAS BEEN USED. EXCESSIVE FORCES AND IMPROPER ENGAGEMENT OF THE DEVICE WITH THE IMPLANT DURING REPEATED USAGE MAY HAVE CONTRIBUTED TO THE FAILURE OF THIS DEVICE. HOWEVER, WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION: THE STEM DISTRACTOR, EXCLUDING THE FRACTURED PIECES, WAS RETURNED FOR EVALUATION. TWO FRACTURE SURFACES ARE OBSERVED ON THE WEDGE COMPONENT; IT IS NOTED THAT THE FRACTURE SURFACES HAVE SIMILAR GEOMETRIES. IN ADDITION, ONE TIP ON THE SLIDE COMPONENT IS SIGNIFICANTLY BENT. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIP FRACTURED OFF WHILE TRYING TO SEPARATE THE SEGMENT FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOST STEM DISTRACTOR KNEE INSTRUMENT LXH ZIMMER, INC. 61348637

    Patients

    Seq Age Sex Outcome Treatment
    1