BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM INTRODUCER

    MDR report key: 3023862 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01116
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING AN EXETER INTRODUCER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A DIFFERENT COMPONENT FROM AN UNKNOWN DEVICE WAS RETURNED. MEDICAL EVALUATION NOT PERFORMED AS MEDICAL RECORDS WERE NOT RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED . A REVIEW OF THE COMPLAINT HISTORY DATABASE COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. THE EXACT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE EVENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    WHILST INSERTING STEM INTO FEMORAL CANAL THE CEMENT WAS CURING QUICKER THAN EXPECTED. THE STEM WAS BECOMING INCREASINGLY HARD TO INSERT DUE TO THIS. TO ASSIST IN INSERTING THE STEM THE SURGEON USED THE MALLET ON THE BACK OF THE STEM INTRODUCER. IT WAS NOTED AFTER THIS THAT THE ROD FOR THE INSERTER WOULD NOT PASS THROUGH THE BULLET TIP.

    Description of Event or Problem · 1

    WHILST INSERTING STEM INTO FEMORAL CANAL THE CEMENT WAS CURING QUICKER THAN EXPECTED. THE STEM WAS BECOMING INCREASINGLY HARD TO INSERT DUE TO THIS. TO ASSIST IN INSERTING THE STEM THE SURGEON USED THE MALLET ON THE BACK OF THE STEM INTRODUCER. IT WAS NOTED AFTER THIS THAT THE ROD FOR THE INSERTER WOULD NOT PASS THROUGH THE BULLET TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125615 EXETER V40 STEM INTRODUCER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other