BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR OFFSET QUICK CONNECT INSERTER

    MDR report key: 3102864 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01589
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K122853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION AND NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THA, A OFFSET INSERTER DID NOT DISSOCIATE FROM AN ACCOLADE2 STEM AFTER STEM INSERTION. THEREFORE, A SURGEON REMOVED IT WITH A HAMMER BY NECESSITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THA, A OFFSET INSERTER DID NOT DISSOCIATE FROM A ACCOLADE2 STEM AFTER STEM INSERTION. THEREFORE, A SURGEON REMOVED IT WITH A HAMMER BY NECESSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204579 MODULAR OFFSET QUICK CONNECT INSERTER INSTRUMENT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other