BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR PROLONG ARTICULAR SURFACE

    MDR report key: 3080897 · Received April 24, 2013

    Report

    Report Number
    1822565-2013-00688
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SUBOPTIMAL ORIENTATION PRIOR TO ATTEMPTED INSERTION APPEARS TO BE THE MOST LIKELY CAUSE OF FAILURE. THE DOVETAIL FEATURE WAS COMPRESSED. THIS TYPICALLY HAPPENS WHEN THE ARTICULAR SURFACE IS NOT OPTIMALLY PLACED AND ORIENTED BEFORE ATTEMPTED INSERTION USING THE ARTICULAR SURFACE INSERTER INSTRUMENT. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO LOCK THE ARTICULAR SURFACE ONTO THE TIBIAL BASEPLATE. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177208 NEXGEN CR PROLONG ARTICULAR SURFACE JWH ZIMMER INC 62257875

    Patients

    Seq Age Sex Outcome Treatment
    1