BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP STEM INSERTER

    MDR report key: 1963831 · Received December 22, 2010

    Report

    Report Number
    1722511-2010-00009
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED INSTRUMENT PRESENTED THREE POTENTIAL ROOT CAUSES FOR THE FAILURE: THE TIP OF THE DEVICE WAS TOO LONG AND BORE THE LOAD OF STEM TORQUE. NO RADIUS WAS PRESENT AT THE BASE OF THE TIP WHERE THE TIP CONNECTS TO THE BODY OF THE HIP STEM INSERTER. INSTRUMENT WAS NOT SUFFICIENTLY HEAT-TREATED.

    Description of Event or Problem · 1

    DURING SURGERY, AS THE SURGEON WAS IMPLANTING A HIP STEM, THE TIP OF THE HIP STEM INSERTION DEVICE BROKE-OFF INSIDE THE HIP STEM. AFTER AN ATTEMPT TO REMOVE THE BROKEN PIECE, THE SURGEON DECIDED TO LEAVE THE BROKEN PIECE IN THE STEM AND CONCLUDE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP STEM INSERTER HIP STEM INSERTER LXH ORTHO DEVELOPMENT CORP. 201-0002 1184007

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention