BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3875277 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02307
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DETAILS WERE REVIEWED AND NO INDICATION WAS FOUND THAT THE EVENT WAS RELATED TO DEVICE DESIGN, MATERIALS, OR MANUFACTURING. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN DURACON LINER. ADDITIONALLY, AN UNKNOWN DURACON FEMUR AND TIBIA WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND THE EVALUATION WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN. IMPLANTS WERE REMOVED AND REVISION WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN. IMPLANTS WERE REMOVED AND REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352930 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention