BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE INSERTION INSTRUMENT

    MDR report key: 1034639 · Received April 25, 2008

    Report

    Report Number
    1822565-2008-00199
    Event Type
    Malfunction
    Date Received
    April 25, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LJW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE DOCTOR SHOULD LOCK THE INSERT OF THE INSTRUMENT, THE TIP PART THAT HAS A SMALL HOOK ON IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE INSERTION INSTRUMENT KNEE INSTRUMENT LJW ZIMMER, INC. NA 60577285

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK