BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAX DURATION 26MM X 41MM

    MDR report key: 3970116 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02947
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K972792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A LOOSE LOCKING RING INVOLVING A CENTRAX DURATION 26MM X 41MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THERE IS NO INDICATION THAT PATIENT FACTORS CONTRIBUTED TO THE REPORTED EVENT. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION NOTED THE DEVICE WAS UNREMARKABLE. A DIMENSIONAL AND FUNCTIONAL INSPECTION WERE NOT PERFORMED AS THE DEVICE WAS AUTOCLAVED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICES WERE AUTOCLAVED UPON RECEIPT AT STRYKER ORTHOPAEDICS. THE AUTOCLAVE ALTERED THE DEVICES DIMENSIONS AND THUS A DIMENSIONAL AND FUNCTIONAL TEST WOULD NOT BE AN ACCURATE REPRESENTATION OF THE DEVICES AT MANUFACTURE CONDITION. NC WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING RING WAS LOOSE IN THE METAL SHELL. THEREFORE, THE SURGEON IMPLANTED A SPARE PRODUCT INSTEAD OF IT, BUT THE SAME EVENT WAS OCCURED. FINALLY, OTHER SIZE CENTRAX (40MM) WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING RING WAS LOOSE IN THE METAL SHELL. THEREFORE, THE SURGEON IMPLANTED A SPARE PRODUCT INSTEAD OF IT, BUT THE SAME EVENT WAS OCCURRED. FINALLY, OTHER SIZE CENTRAX (40MM) WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446838 CENTRAX DURATION 26MM X 41MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH A12E189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other