BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNEXGEN STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 2093260 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01097
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASSEMBLED TIBIAL BASEPLATE AND STEM WOULD NOT SIT DOWN FLUSH DURING ATTEMPTED INSERTION. ANOTHER TIBIAL BASEPLATE WAS USED WITHOUT A STEM TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LNEXGEN STEMMED TIBIAL COMPONENT PRECOAT JWH ZIMMER 61717251

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # 61618946, (B(4)| NEXGEN STEM EXTENSION OFFSET, CATALOG #00598802011