BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRH BUSHING STANDARD

    MDR report key: 1791765 · Received August 4, 2010

    Report

    Report Number
    2249697-2010-00999
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K792089
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICES CANNOT BE PERFORMED AS THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICES REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICES OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PER SUBMITTED AS IT IS REVISION SURGERY ONLY. PATIENT HAD OSTEOSARCOMA OF LEFT KNEE, TUMOR WAS RESECTED AND REPLACED WITH MODULAR ROTATING DISTAL FEMUR IN ABOUT 1991. THE BUSHINGS WERE REPLACED IN 1999 PATIENT HAD INSTABILITY AND PAIN IN THE KNEE RECENTLY. SO THE BUSHINGS WERE REPLACED. BUSHINGS WERE SLIGHTLY WORN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRH BUSHING STANDARD IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention