BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR FEMORAL COMPONENT/CEMENTED #3 LEFT

    MDR report key: 1844668 · Received September 20, 2010

    Report

    Report Number
    9610726-2010-00327
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 7, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON REPORTS VIA OUR CLINICAL DEPARTMENT ABOUT ARTHROFIBROSIS. MOBILISATION IN ANESTHESIA WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR FEMORAL COMPONENT/CEMENTED #3 LEFT IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SJBPD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention