BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2566114 · Received May 3, 2012

    Report

    Report Number
    1822565-2012-00968
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 4, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: DIMENSIONAL ANALYSIS SHOWS THAT THE DEVICE IS CONFORMING TO PRINT SPECS. VISUAL EXAMINATION OF THE ARTICULAR SURFACE REVEALS DAMAGE TO THE DOVETAIL, INDICATING THAT IT DID NOT PROPERLY SLIDE 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 INSTRUMENT. IT IS POSSIBLE THAT THE PROBLEMS ENCOUNTERED ARE RELATED TO SURGICAL TECHNIQUE; HOWEVER MOE INFO WOULD BE NEEDED TO CONCLUSIVELY MAKE THAT DETERMINATION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 IS REPORTED THAT THE SURGEON HAD DIFFICULTY INSERTING THE POLY INTO THE TIBIA TRAY. SURGERY WAS COMPLETED WITH ANOTHER POLY WHICH SEATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE MBH ZIMMER, INC. 61929606

    Patients

    Seq Age Sex Outcome Treatment
    1