BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 1871281 · Received October 12, 2010

    Report

    Report Number
    2249697-2010-01350
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS KEPT BY THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2010-01351.

    Description of Event or Problem · 1

    AT (B)(4). IT WAS REPORTED THAT, "(B)(6) REVISED THE KNEE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED. HE REMOVED IT BY HAND. THE FEMUR WAS NOT FRANKLY LOOSE, BUT CAME OFF EASILY. THE PATELLA WAS WELL FIXED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T04V738

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention