BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN IM FEMORAL A/P SIZING GUIDE

    MDR report key: 3000130 · Received February 14, 2013

    Report

    Report Number
    1822565-2013-00282
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 16, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNKNOWN THE MAGNITUDE WITH WHICH THE DEVICE WAS BEING STRUCK. THE PACKAGE INSERT FOR THE DEVICE STATES, "DO NOT SUBJECT INSTRUMENTS TO HIGH LOADS AND/OR IMPACT AS BREAKAGE CAN OCCUR". IT IS ALSO UNKNOWN HOW OFTEN THIS INSTRUMENT WAS USED PRIOR TO THIS INCIDENT. THE DEVICE WAS MANUFACTURED 06/20/1996; IT WAS THEREFORE POTENTIALLY IN USE FOR 16 YEARS. THE DEVICE APPEARS TO HAVE EXCEEDED ITS USEFUL LIFE. AS RETURNED THE DEVICE WAS OBSERVED TO HAVE BEEN FRACTURED AT THE WELD WHERE THE IM ROD ATTACHED TO THE JIG AND WAS WORN AND DAMAGED IN OTHER PLACES. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE FEMORAL GUIDE SHAFT BROKE DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65385 NEXGEN IM FEMORAL A/P SIZING GUIDE FZX ZIMMER, INC. 74779100

    Patients

    Seq Age Sex Outcome Treatment
    1