BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION SPIKE ARM

    MDR report key: 2151235 · Received June 21, 2011

    Report

    Report Number
    1822565-2011-01476
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 25, 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

    EVALUATION SUMMARY: AS RETURNED, THE LONGER OF THE TWO SPIKES HAS FRACTURED AT ITS BASE. MATERIAL HARDNESS IS CONFORMING TO PRINT SPECIFICATION. THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROX 10 YEARS. FRACTURE OF THE SPIKES MAY BE ATTRIBUTED TO SEVERAL FACTORS, SOME OF WHICH MAY INCLUDE: THE ABSENCE OF A RADIUS AT THE BASE OF THE SPIKES, OFF-AXIS IMPACTION, AND/OR DEGRADATION OF THE MATERIAL PROPERTIES DUE TO AGE AND USE. DUE TO THE AGE OF THE DEVICE THIS FAILURE CAN BE MOST LIKELY ATTRIBUTED TO THE DEVICE EXCEEDING ITS USEFUL LIFE DUE TO NORMAL WEAR. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE REMOVING THE SPIKE ARM, THE SPIKE BROKE OFF IN THE PT'S TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION SPIKE ARM LXH ZIMMER INC 70295500

    Patients

    Seq Age Sex Outcome Treatment
    1