BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2831045 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02134
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    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 DREXEL IMPLANT RESEARCH CENTER. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTERS INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2012-02135.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTHROPLASTY WAS REVISED DUE TO LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROXIMATELY 15.8 Y. THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED. THE PATIENT PRESENTED WITH A (B)(4) SCORE OF 2 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA T05S718

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention