BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 4171068 · Received July 15, 2014

    Report

    Report Number
    2648920-2014-00177
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ZIMMER
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IT IS POSSIBLE THAT THE ISSUES ENCOUNTERED ARE RELATED TO SURGICAL TECHNIQUE; HOWEVER, THIS CANNOT BE DETERMINED DEFINITIVELY. EVAL CODES: AN EVAL OF THE DEVICE CONCLUDED THAT ONE SIDE OF THE INNER DOVETAIL LIPS IS SEVERELY COMPRESSED DOWN, 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. THERE ARE ALSO TWO GOUGES ON THE UNDERSIDE OF THE ARTICULAR SURFACE; HOWEVER, IT IS UNK WHAT CAUSED THESE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS UNABLE TO GET THE POLY TO SEAT PROPERLY. A SECOND POLY WAS OPENED AND THE NEW SURFACE LOCKED IN PERFECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413340 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE MBH ZIMMER 62160312

    Patients

    Seq Age Sex Outcome Treatment
    1