BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LEGACY PROVISIONAL/CUTTING GUIDE

    MDR report key: 1923212 · Received November 9, 2010

    Report

    Report Number
    1822565-2010-01095
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    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: AS RETURNED, THE PROVISIONAL WAS FRACTURED THROUGH THE DISTAL CONDYLES. ACCORDING TO THE SEM ANALYSIS, THE FRACTURE APPEARS TO HAVE OCCURRED BY REPEATED IMPACT LOADING. THE FRACTURED SURFACE SHOWS A DENDRITIC STRUCTURE AND THE CRACK ARREST MARKS. MECHANICAL DEFORMATION ON THE FRACTURED SURFACE WAS ALSO OBSERVED WHICH COULD HAVE HAPPENED AFTER THE FRACTURE OCCURRED. THIS PART WAS MANUFACTURED IN (B)(4) 2002, WHICH MAKES ITS POTENTIAL FIELD AGE ALMOST 8 YEARS. HOWEVER, USAGE CANNOT BE DETERMINED SINCE THIS IS A REUSABLE DEVICE. THIS DEVICE IS INTENDED FOR REPEATED IMPACTION, BUT WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION: DEVICE HISTORY RECORDS INDICATES ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS / ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING IMPACTION OF THE PROVISIONAL ONTO THE FEMUR, THE PROVISIONAL BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY PROVISIONAL/CUTTING GUIDE KNEE INSTRUMENT LXH ZIMMER, INC. 07779000

    Patients

    Seq Age Sex Outcome Treatment
    1