BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 3002329 · Received March 7, 2013

    Report

    Report Number
    2648920-2013-00068
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBOPTIMAL ORIENTATION PRIOR TO ATTEMPTED INSERTION APPEARS TO BE THE MOST LIKELY CAUSE OF FAILURE. AS RETURNED, THE MEASURED DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. THE DOVETAIL FEATURE IS COMPRESSED; THIS TYPICALLY HAPPENS WHEN THE ARTICULAR SURFACE IS NOT OPTIMALLY PLACED AND ORIENTED BEFORE ATTEMPTED INSERTION USING THE ARTICULAR SURFACE INSERTER INSTRUMENT. MFG DOCUMENTATION WAS REVIEWED AND INDICATES THAT THE DEVICE WAS MFG, INSPECTED AND PACKAGED TO SPECIFICATION .

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON TWO ATTEMPTS TO IMPLANT ARTICULAR SURFACE, THE POLY WOULD NOT FULLY SEAT. THE SURGEON ASKED FOR ANOTHER POLY AND IT WAS INSERTED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96799 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE JWH ZIMMER 62215437

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR