BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRH DURATION BUSHING STANDARD

    MDR report key: 3476525 · Received November 19, 2013

    Report

    Report Number
    0002249697-2013-03744
    Event Type
    Injury
    Date Received
    November 19, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K972863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 6485-4-100, LOT LPTB856, DESCRIPTION: KRH DURATION STANDARD BUMPER. CAT 6495-1-001, LOT SYM7M, DESCRIPTION: PROXIMAL FEM COMP STD. CAT 6260-9-126, LOT 36518404, DESCRIPTION: 26MM STD LFIT V40 HEAD. CAT UH1-46-26, LOT MKD77J, DESCRIPTION: UHR BIPOLAR 26X46MM. CAT 6475-3-940, LOT LTBR12, DESCRIPTION: KRH STANDARD AXLE. CAT 6495-6-070, LOT SYNFD, DESCRIPTION: GMRS EXTENSION PIECE 70MM. CAT 6495-6-019, LOT CTD349, DESCRIPTION: GMRS EXTENSION PIECE 90MM RHT. CAT 6495-6-080, LOT S3EJN, DESCRIPTION: GMRS EXTENSION PIECE 80MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A KRH BUSHING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTIONS WERE NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT OR STERILE LOT. THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT OR STERILE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED, FURTHER INFORMATION IS NEEDED.

    Description of Event or Problem · 1

    THE PATIENT HAD OSTEOSARCOMA AND ON (B)(6) 1993, THE TUMOR WAS IN THE PATIENT RIGHT KNEE WHICH WAS REPLACED BY AN MRS DISTAL FEMUR. ON (B)(6) 2011, PATIENT FRACTURED RIGHT PROXIMAL FEMUR WAS REPLACED WITH A GMRS PROXIMAL FEMUR WITH A UH1 BIPOLAR HIP. THE PROXIMAL FEMUR AND DISTAL FEMUR WERE CONNECTED RESULTING IN A TOTAL FEMUR. ON (B)(4) 2013, PATIENT WAS OPERATED ON AGAIN DUE TO SUSPICION OF INFECTION WHICH WAS CONFIRMED. THE POLYETHYLENE COMPONENTS WERE REPLACED AND ALL METAL PIECES WERE WASHED, ULTRASONICALLY CLEANED AND STERILIZED AT (B)(6). THE METAL SHAFT OF THE TOTAL FEMUR IMPLANT WAS THEN COATED WITH OUR TOBRA CEMENT. THEN EVERYTHING WAS PUT BACK INTO THE RIGHT LEG AND THE WOUND CLOSED.

    Description of Event or Problem · 1

    THE PATIENT HAD OSTEOSARCOMA AND ON (B)(6), 1993, THE TUMOR WAS IN THE PATIENT RIGHT KNEE WHICH WAS REPLACED BY AN MRS DISTAL FEMUR. ON (B)(6), 2011, PATIENT FRACTURED RIGHT PROXIMAL FEMUR WAS REPLACED WITH A GMRS PROXIMAL FEMUR WITH A UH1 BIPOLAR HIP. THE PROXIMAL FEMUR AND DISTAL FEMUR WERE CONNECTED RESULTING IN A TOTAL FEMUR. ON (B)(6), 2013, PATIENT WAS OPERATED ON AGAIN DUE TO SUSPICION OF INFECTION WHICH WAS CONFIRMED. THE POLYETHYLENE COMPONENTS WERE REPLACED AND ALL METAL PIECES WERE WASHED, ULTRASONICALLY CLEANED AND STERILIZED AT (B)(6). THE METAL SHAFT OF THE TOTAL FEMUR IMPLANT WAS THEN COATED WITH OUR TOBRA CEMENT. THEN EVERYTHING WAS PUT BACK INTO THE RIGHT LEG AND THE WOUND CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598308 KRH DURATION BUSHING STANDARD IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LPTB839

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention