BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR FEMORAL COMPONENT/CEMENTED #5 RIGHT

    MDR report key: 1844659 · Received September 20, 2010

    Report

    Report Number
    9610726-2010-00326
    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 SEVERE MEDICAL AND LATERAL PAIN. AN ARTHROSCOPY IS PLANNED ON (B)(6), 2010, FOR FURTHER DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR FEMORAL COMPONENT/CEMENTED #5 RIGHT IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SH78A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other