BEUDAMED
    FDA Adverse Event Injury Summary report: N

    # 6 TRIATHLON CR FEMUR

    MDR report key: 2233976 · Received August 31, 2011

    Report

    Report Number
    2249697-2011-01301
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN NUMBER 5 CRUCIFORM BASEPLATE, UNKNOWN 5X9MM CR INSERT AND UNKNOWN 33X9 PATELLA WERE ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVALUATION OF THE DEVICE(S) CANNOT BE PERFORMED AS THE DEVICE(S) WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD DEVICE(S) OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATIENT COMPLAINED OF PAIN. ALL COMPONENTS SEEMED FINE. HOWEVER, FEMUR REVISED TO A TS FEMUR AND A PS TIBIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 # 6 TRIATHLON CR FEMUR IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention