BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI DUR REG FLUTED STEM 11X155MM

    MDR report key: 1844871 · Received September 22, 2010

    Report

    Report Number
    9610726-2010-00335
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K973164
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICES CANNOT BE PERFORMED AS THEY WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO PERTAINING TO THE DEVICES REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 9610726-2010-00334.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SHE HAD PAIN WITH THE STEMS IN BOTH HER FEMUR AND TIBIA. THE PLAN WAS TO REMOVE THESE AND PLACE SHORTER CEMENTED STEMS TO ALLEVIATE HER PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI DUR REG FLUTED STEM 11X155MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention