BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO CR WAFFLE FEMUR LFIT W/POSTS

    MDR report key: 1163107 · Received September 16, 2008

    Report

    Report Number
    2249697-2008-00271
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSA
    PMA / PMN Number
    K974556
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SCORPIO FEMORAL COMPONENT REVISED DUE TO INCREASE PAIN AND SWELLING, ACCORDING TO THE SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO CR WAFFLE FEMUR LFIT W/POSTS IMPLANT HSA STRYKER ORTHOPAEDICS MAHWAH NA K03V967A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention