BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 35.5MM

    MDR report key: 4221388 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04102
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING LOOSENING INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE STEM WAS RETURNED TO THE SUPPLIER FOR EVALUATION AND CONFIRMED THAT THE DEVICE WAS DIMENSIONALLY COMPLIANT DEVICE HISTORY REVIEW: 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. CONCLUSIONS: THE EXACT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. FURTHER INFORMATION SUCH AS OPERATIVE NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXETER STEM WAS INSERTED AFTER FILLED THE CEMENT. WHEN DISLOCATING THE HEAD TRIAL, THE STEM LOOSENING OCCURRED. AFTER THAT THE STEM WAS PULLED OUT, THE CEMENT WAS ADDED AND THE OTHER SIZE STEM WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXETER STEM WAS INSERTED AFTER FILLED THE CEMENT. WHEN DISLOCATING THE HEAD TRIAL, THE STEM LOOSENING OCCURRED. AFTER THAT THE STEM WAS PULLED OUT, THE CEMENT WAS ADDED AND THE OTHER SIZE STEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701189 EXETER V40 STEM 35.5MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G5044887

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other