BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 3895075 · Received June 25, 2014

    Report

    Report Number
    0002249697-2014-02431
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY AND NO FURTHER INFORMATION WOULD BE PROVIDED. DEVICE HISTORY RECORDS FOR THE SPECIFIC LOT INDICATED THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR THE SUBJECT LOT CODE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL REQUIRING A REVISION OF HER RIGHT HIP'S FEMORAL COMPONENTS. MDM LINER WAS EXCHANGED FOR A 36 X3 LINER AND EXETER STEM WAS REVISED TO A ZIMMER WAGNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372024 EXETER V40 STEM 44MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G3070389

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R