BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3221803 · Received July 5, 2013

    Report

    Report Number
    1822565-2013-01077
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THIS TYPICALLY HAPPENS WHEN THE ARTICULAR SURFACE IS NOT OPTIMALLY PLACED AND ORIENTED BEFORE ATTEMPTED INSERTION USING THE ARTICULAR SURFACE INSERTER INSTRUMENT. IT IS POSSIBLE THAT THE PROBLEMS ENCOUNTERED ARE RELATED TO SURGICAL TECHNIQUE; HOWEVER, MORE INFO WOULD BE NEEDED TO CONCLUSIVELY MAKE THAT DETERMINATION. EVAL: AS RETURNED, THE ARTICULAR SURFACE IS WITHIN SPEC WHERE MEASURED. IT EXHIBITS AN INDENTATION ON ONE SIDE OF THE DOVETAIL, WHICH COULD INDICATE THAT THE ARTICULAR SURFACE DID NOT FULLY SLIDE UNDER THE MALE DOVETAIL ON THE TIBIAL PLATE. 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 ADD'L 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 APPROX 5 TIMES TO SEAT THE ARTICULAR SURFACE BUT WAS NOT SUCCESSFUL. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE WHICH IMPLANTED WITH NO DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308246 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 62312589

    Patients

    Seq Age Sex Outcome Treatment
    1