BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 44MM NO 3

    MDR report key: 3970114 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02941
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A DIFFICULTY TO FIT A SPIGOT TO THE EXETER STEM INTRODUCER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. 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 PROVIDED. DEVICE ANALYSIS OF THE SPIGOT AND INTRODUCER ARE REQUIRED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT THE NECK PROTECTOR ON THE EXETER STEM WOULD NOT FIT INTO THE STEM INTRODUCER. A STRAIGHT NAIL WAS USED AS A PUSHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT THE NECK PROTECTOR ON THE EXETER STEM WOULD NOT FIT INTO THE STEM INTRODUCER. A STRAIGHT NAIL WAS USED AS A PUSHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446715 EXETER V40 STEM 44MM NO 3 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G4022963

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other