BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 33MM

    MDR report key: 2202394 · Received August 4, 2011

    Report

    Report Number
    9616680-2011-00519
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 22, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K891454
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMORAL IMPLANT HAD FRACTURED. PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 33MM IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA GB838671

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention