BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2032677 · Received March 17, 2011

    Report

    Report Number
    2249697-2011-00335
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE X-RAYS AND MEDICAL RECORDS WERE REQUESTED, BUT NOT MADE AVAILABLE. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "TIBIAL TRAY WAS FOUND TO BE LOOSE. SURGEON USED A REVISION TIBIAL TRAY WITH X3 FLEX PS TIBIAL INSERT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T00S275

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention