BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE INSERTION INSTRUMENT

    MDR report key: 1081868 · Received July 21, 2008

    Report

    Report Number
    1822565-2008-00432
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE HEX ON THE ATTACHMENT SCREW SHOWS DEFORMATION MARKS INDICATING THE POSSIBLE DISASSEMBLY OF THE DEVICE IN THE FIELD. IT IS POSSIBLE THAT THE PARTS WERE NOT ASSEMBLED BACK PROPERLY OR THE BALL BEARING WAS LOST. EVIDENTLY, THE PROBLEM IS USER CAUSED. EVALUATION: THE DEVICE IS MISSING THE BALL BEARING FROM THE DISTAL END OF THE CAM ARM. THE BALL BEARING WAS RETURNED WITH THE COMPLAINT FOR REVIEW AND EXHIBITS SOME DEFORMATION DAMAGE. THE CAM ARM RETAINING SCREW APPEARS TO HAVE BEEN DISASSEMBLED FROM THE DEVICE AT SOME TIME. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE REPORTED MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY IN THE PREVIOUS TWO YEARS ON A SAME OR SIMILAR DEVICE. AS A RESULT, THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING FOR MANUFACTURER GUIDANCE DOCUMENT PUBLISHED BY THE FDA IN 1997.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE PREPARING FOR SURGERY, THE BALL BEARING OF THE ARTICULAR INSERTER FELL OUT. IT WAS LATER RETRIEVED AND DID NOT AFFECT PATIENT/SURGERY OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE INSERTION INSTRUMENT KNEE INSTRUMENT LXH ZIMMER, INC. NA 74233500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK