BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2142419 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00930
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 1, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT REPORTED PAIN. SURGEON DETERMINED THAT THE PT'S IMPLANT LOOSENED, HAD MALALIGNMENT WITH BONE LOSS SO HE REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T04K1153

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention