BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV STRAIGHT CUP POSITIONER

    MDR report key: 3150713 · Received June 6, 2013

    Report

    Report Number
    0002249697-2013-01853
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    REP STATES THE NAVIGATED IMPACTOR WAS BROKEN DURING IMPACTION USING ORTHOMAP MODULAR HIP SOFTWARE. THE NAVIGATION TRACKER ADAPTER ON THE IMPACTOR BROKE CAUSING THE TRACKER TO FALL OFF THE IMPACTOR.

    Description of Event or Problem · 1

    REP STATES THE NAVIGATED IMPACTOR WAS BROKEN DURING IMPACTION USING ORTHOMAP MODULAR HIP SOFTWARE. THE NAVIGATION TRACKER ADAPTER ON THE IMPACTOR BROKE CAUSING THE TRACKER TO FALL OFF THE IMPACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250783 NAV STRAIGHT CUP POSITIONER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other