BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 776949 · Received October 31, 2006

    Report

    Report Number
    2249697-2006-00131
    Event Type
    Injury
    Date Received
    October 31, 2006
    Date of Event
    August 16, 2006
    Report Date
    October 9, 2006
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT CANNOT YET BE DETERMINED WHETHER THE REPORTED DEVICE OR THE ASSOCIATED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. OTHER DEVICES LISTED IN THE REPORT: 72-3-1108 SCORPIO PS TIBIAL INSERT LOT 06965301; 71-3011R SCORPIO PS BASIC FEMUR LOT K0371268.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT IN 2004. THE SURGEON REPORTED THAT THE SURGERY AND POST OP X-RAYS WERE SATISFACTORY. THE CUSTOMER FURTHER STATED THAT, IN 2006, THE PT UNDERWENT A REVISIONARY PROCEDURE BECAUSE OF INCREASING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T03T1234

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention