BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROLONG CR ARTICULAR SURFACE

    MDR report key: 3111763 · Received May 7, 2013

    Report

    Report Number
    1822565-2013-00753
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 8, 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

    EVAL SUMMARY: SUBOPTIMAL ORIENTATION PRIOR TO ATTEMPTED INSERTION APPEARS TO BE THE MOST LIKELY CAUSE OF FAILURE. THE SURGICAL TECHNIQUE FOR THIS DEVICE STATES "INSERT AN ARTICULAR SURFACE ONLY ONCE. NEVER REINSERT THE SAME ARTICULAR SURFACE ONTO A TIBIAL BASE PLATE." THE MEASURED DIMENSIONS OF THE DEVICE WERE FOUND TO BE WITHIN SPEC AS RETURNED; THE DOVETAIL FEATURE WAS DEFORMED. THIS TYPICALLY HAPPENS WHEN THE ARTICULAR SURFACE IS NOT OPTIMALLY PLACED AND ORIENTED BEFORE ATTEMPTED INSERTION USING THE ARTICULAR SURFACE INSERTER INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT FULLY LOCK ONTO THE TIBIAL COMPONENT. ANOTHER ARTICULAR SURFACE WAS OPENED AND INSERTED WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199978 NEXGEN PROLONG CR ARTICULAR SURFACE JWH ZIMMER, INC. 62263869

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR