BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 SANDARD TIBIA

    MDR report key: 1060905 · Received June 13, 2008

    Report

    Report Number
    2249697-2008-00172
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFORMATION A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "LOOSENING, STIFFNESS, PAIN IN L KNEE. TIBIAL COMPONENT GROSSLY LOOSE AND IN VARUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 SANDARD TIBIA IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA I05E868

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention