BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 3142837 · Received May 24, 2013

    Report

    Report Number
    1822565-2013-00870
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS POSSIBLE THAT THE PROBLEM ENCOUNTERED ARE RELATED TO SURGICAL TECHNIQUE; HOWEVER, MORE INFO WOULD BE NEEDED TO CONCLUSIVELY MAKE THAT DETERMINATION. EVAL CODES: THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING; INDICATING THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECS. DIMENSIONAL ANALYSIS WAS PERFORMED AND FOUND THE PRODUCT TO BE CONFORMING TO PRINT SPECS. VISUAL EXAMINATION SHOWS DAMAGE TO THE DOVETAIL FEATURE AND THE POSTERIOR BOTTOM EDGE OF THE DEVICE. DAMAGE TO THE DOVETAIL INDICATED THAT THE DEVICE MAY NOT HAVE BEEN PROPERLY POSITIONED PRIOR TO ATTEMPTED INSERTION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT STAY SEATED IN THE TIBIAL TRAY DURING FLEXION, PRIOR TO INSERTION OF THE LOCKING SCREW. ANOTHER ARTICULAR SURFACE WAS OPENED AND INSERTED WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231137 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER, INC. 60722034

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR