BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 3941016 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02771
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. HOSPITAL DISPOSED THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A REVISION HIP ON A PATIENT DUE TO A PERI-PROSTHETIC FRACTURE. ORIGINAL EXETER STEM WAS REMOVED AND REVISED WITH ANOTHER STANDARD LENGTH (44#0, 150MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419561 EXETER V40 STEM 44MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R