BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3002334 · Received March 7, 2013

    Report

    Report Number
    2648920-2013-00066
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEFORMATION OF THE DOVETAIL CAN TAKE PLACE WHEN THE ARTICULAR SURFACE IS NOT OPTIMALLY PLACED AND ORIENTED BEFORE ATTEMPTED INSERTION USING THE ARTICULAR SURFACE INSERTER INSTRUMENT. SUBOPTIMAL ORIENTATION PRIOR TO ATTEMPTED INSERTION MAY BE WHAT CAUSED THIS REPORTED INCIDENT; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. THE DEVICE IS REPORTED TO HAVE BEEN DISCARDED. EVAL CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT THE ARTICULAR SURFACE, BUT IT WOULD NOT SEAT PROPERLY. ANOTHER IMPLANT WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97262 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE JWH ZIMMER 62176641

    Patients

    Seq Age Sex Outcome Treatment
    1