BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M/G UNICOMPARTMENTAL TENSION GAUGE

    MDR report key: 1831972 · Received September 7, 2010

    Report

    Report Number
    1822565-2010-00656
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 23, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THIS IS A PLASTIC PART AND WILL TEND TO BREAK DUE TO REPEATED EXPOSURE TO LARGE BENDING FORCES THAT CAN OCCUR DURING USE. IN THIS CASE, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY DUE TO REPEATED HIGH BENDING LOAD WHICH FINALLY CAUSED THE FRACTURE. THE INSTRUMENT WAS FRACTURED INTO TWO PIECES ON THE 2MM THICK END AND BOTH PIECES WERE RETURNED FOR REVIEW. THE FRACTURE OCCURRED ACROSS THE WIDTH OF THE INSTRUMENT, NOT THE LENGTH. MEASUREMENTS OF THE INSTRUMENT WERE FOUND TO BE CONFORMING TO SPECIFICATIONS. IT IS NOT KNOWN HOW LONG THIS DEVICE WAS IN SERVICE; HOWEVER, VISUALLY THIS INSTRUMENT APPEARS TO BE OLDER BASED ON A DARKER COLOR AND THE NICKS AROUND THE EDGES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TENSION GAUGE BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/G UNICOMPARTMENTAL TENSION GAUGE KNEE INSTRUMENT LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1