BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS FLEX ARTICULAR SURFACE

    MDR report key: 2110019 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01175
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: AS RETURNED, THE SURFACE EXHIBITS DAMAGE TYPICAL OF A FAILED ATTEMPT TO INSTALL. DAMAGE TO THE DOVETAIL IS NOTED, LIKELY A RESULT OF THE REPORTED INSERTION. BASED ON THE DAMAGE SEEN, IT IS POSSIBLE THAT THE ARTICULAR SURFACE WAS INSERTED AT A SUB-OPTIMAL ANGLE, THUS CAUSING THE DOVETAIL TO NOT ENGAGE PROPERLY. WITHOUT FURTHER INFO, HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. EVAL: DIMENSIONAL READINGS ARE CONFORMING TO PRINT SPECS. MFG DOCUMENTATION FOR THE DEVICE WAS REVIEWED AND INDICATES IT WAS MFG, INSPECTED, AND PACKAGED TO SPEC.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE 12MM ARTICULAR SURFACE WAS EASILY RAISED, THEREFORE, THE SURGEON IMPLANTED A 10MM ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61651996

    Patients

    Seq Age Sex Outcome Treatment
    1