BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 40MM/-4

    MDR report key: 2821465 · Received October 23, 2012

    Report

    Report Number
    2249697-2012-02030
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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, COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 40MM/-4 IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA PM4MAE

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention