BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 3896515 · Received May 19, 2014

    Report

    Report Number
    2648920-2014-00126
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    June 24, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Removal / Correction Number
    2648920-05/19/2014-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MDR#: 1822565-2010-01717 FOR THE INITIAL REPORT SUBMITTED FOR THIS EVENT. NO OUT OF SPECIFICATION CONDITION HAS BEEN CONFIRMED FOR THE MIS TIBIAL COMPONENT REPORTED IN THIS EVENT. HOWEVER, REVIEW OF PRODUCT FOR MDR# 2648920-2013-00272 FOUND THAT REPORTED LOT TO HAVE MATING THREADS WHICH ARE OUT OF SPECIFICATION. THE SCOPE OF THE INVESTIGATION WAS EXPANDED TO INCLUDE THE TIBIAL COMPONENT REPORTED FOR THIS EVENT. AS A RESULT, FIELD ACTION (B)(4) IS BEING INITIATED. THIS REMOVAL REPORT CAN BE REFERENCED FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO INSERT THE 75MM DROP DOWN STEM INTO THE TIBIA PLATE. THE SURGERY WAS COMPLETED WITH A 45MM STEM, WHICH WAS ALSO DIFFICULT TO INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297819 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER 61643930

    Patients

    Seq Age Sex Outcome Treatment
    1