BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 37.5MM NO 0

    MDR report key: 3923044 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02576
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE AND EXPIRATION DATE CORRECTED. AN EVENT REGARDING DAMAGED SPIGOTS INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS. THE DEVICES WERE NOT RETURNED FOR EVALUATION. PHOTOGRAPHS WERE PROVIDED AND REVIEWED. THERE IS EVIDENCE TO INDICATE THAT THE LUG OF THE SPIGOT IS DAMAGED. MEDICAL EVALUATION NOT PERFORMED AS MEDICAL RECORDS WERE NOT RECEIVED FOR EVALUATION. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. THE EXACT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES BUSINESS MANAGER THAT DURING A PROCEDURE THREE SPIGOT PROTECTORS WERE FOUND TO HAVE MOULDING FAULTS. THE CUSTOMER REPORTED THAT ONE OF THE 'PRONGS' WAS FOUND TO BE OUT OF ALIGNMENT ON ALL THREE DEVICES. THE CUSTOMER REPORTED THAT ONE DEVICE WAS DISCARDED BUT TWO WERE KEPT FOR INVESTIGATION. THE CUSTOMER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH LESS THAN A FEW MINUTES DELAY TO SURGERY TIME AS A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES BUSINESS MANAGER THAT DURING A PROCEDURE THREE SPIGOT PROTECTORS WERE FOUND TO HAVE MOULDING FAULTS. THE CUSTOMER REPORTED THAT ONE OF THE 'PRONGS' WAS FOUND TO BE OUT OF ALIGNMENT ON ALL THREE DEVICES. THE CUSTOMER REPORTED THAT ONE DEVICE WAS DISCARDED BUT TWO WERE KEPT FOR INVESTIGATION. THE CUSTOMER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH LESS THAN A FEW MINUTES DELAY TO SURGERY TIME AS A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400539 EXETER V40 STEM 37.5MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G3907853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other