BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3248200 · Received July 25, 2013

    Report

    Report Number
    0002249697-2013-02455
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN MODULAR STEM EXTRACTOR. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN INSTRUMENT NOT FUNCTIONING CORRECTLY INVOLVING A UNKNOWN MODULAR STEM EXTRACTOR WAS REPORTED. A PHOTOGRAPH OF THE DEVICE ASSEMBLED WITH AN FEMORAL STEM WAS PROVIDED. NOTHING CAN BE LEARNED FROM THIS PHOTOGRAPH. THE EVENT WAS NOT CONFIRMED. IT IS NOT BELIEVED THAT PATIENT FACTORS CONTRIBUTED TO THE REPORTED EVENT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION OF THE ABGII, THE MODULAR STEM EXTRACTOR FAILED TO FUNCTION CORRECTLY. THE LOCKING PIN ENGAGED AND PUSHED THE NECK CONNECTION AWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION OF THE ABGII THE MODULAR STEM EXTRACTOR FAILED TO FUNCTION CORRECTLY. THE LOCKING PIN ENGAGED AND PUSHED THE NECK CONNECTION AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347571 UNKNOWN_RECONSTRUCTIVE_PRODUCT INSTRUMENT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other