BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2831076 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02140
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. DEVICES WERE RETAINED AT (B)(6). MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTION AT REPORTER'S INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE ARTHROPLASTY WAS REVISED DUE TO TIBIAL LOOSENING AND MEDIAL/LATERAL LAXITY. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROXIMATELY 4.0 Y. THE TIBIAL INSERT, TIBIAL TRAY, PATELLA AND FEMORAL COMPONENTS WERE REVISED. THE PT PRESENTED WITH A UCLA SCORE OF 3 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORHTOPAEDICS MAHWAH NA 9H1MHE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention