BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR ARTICULAR SURFACE

    MDR report key: 2861512 · Received November 28, 2012

    Report

    Report Number
    1822565-2012-02368
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE INNER (SMALL) DOVETAIL EXHIBITS AN INDENTATION ALONG THE EDGE, INDICATING THAT THE ARTICULAR SURFACE MAY NOT HAVE PROPERLY SLID UNDER THE MALE DOVETAIL ON THE TIBIA PLATE. THIS MAY INDICATE THAT THE ARTICULAR SURFACE WAS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENTS. INCORRECT PLACEMENT OR ORIENTATION OF THE ARTICULAR SURFACE RESULTING IN INSERTION DIFFICULTIES AND COMPRESSION OF THE DOVETAIL FEATURE HAS BEEN SEEN PREVIOUSLY. INCORRECT MAY HAVE BEEN THE CAUSE OF THE PROBLEM; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. AS RECEIVED, THE 3.126 +-.006 INCH DIMENSION WAS SLIGHTLY UNDER SPEC (3.117 INCH), WHICH COULD HAVE RESULTED FROM HIGH TEMPERATURE EXPOSURE; THE METHOD OF DECONTAMINATION PRIOR TO SHIPPING TO ZIMMER WAS NOT STATED. ALL OTHER MEASURED DIMENSIONS WERE WITHIN SPEC. AS RECEIVED, VISUAL INSPECTION REVEALED A SLIGHT DISTORTION OF THE DOVETAIL LOCKING FEATURE; THIS IS CONSISTENT WITH EXPOSURE TO A HEAT RELATED EVENT. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPEC.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ARTICULAR SURFACE COULD NOT BE PUT ON THE TIBIAL BASEPLATE. ANOTHER ONE WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR ARTICULAR SURFACE JWH ZIMMER, INC. 62046802

    Patients

    Seq Age Sex Outcome Treatment
    1