BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3846270 · Received June 3, 2014

    Report

    Report Number
    0002249697-2014-02068
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN KINEMATIC ROTATING HINGE CUSTOM FEMUR CIRCA 1987. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FEMORAL COMPONENT AND TIBIAL STEM LOOSENING INVOLVING AN UNKNOWN CUSTOM KHR FEMORAL COMPONENT WAS REPORTED. THE FEMORAL COMPONENT LOOSENING EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. VISUAL INSPECTION OF A PHOTOGRAPH OF THE EXPLANTED DEVICES DID NOT PROVIDE ANYTHING OF NOTE TO THIS INVESTIGATION. MEDICAL RECORDS RECEIVED AND EVALUATION: MEDICAL REVIEW COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION AVAILABLE HOWEVER THE FOLLOWING COMMENTS WERE MADE BY OUR CLINICAL CLINICIAN; NO RADIOLOGY PRESENT ON THE FEMORAL SIDE. CONCLUSIONS: MEDICAL REVIEW COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EARLY POST IMPLANTATION X-RAYS AND X-RAYS OF THE FEMORAL SIDE WOULD HELP DETERMINE THE ROUTE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    PATIENT WAS PLAYING TENNIS AND WITH HER FOOT PLANTED, MADE A TWIST AND FELT THE SENSATION IN THE KNEE. AT SURGERY THE KRH FEMUR WAS FOUND TO BE LOOSE. THE GMRS PROX TIBIA WAS LOOSE. THE COMPONENTS WERE REPLACED WITH A SMALL GMRS DISTAL FEMUR AND A SMALL GMRS PROXIMAL FEMUR.

    Description of Event or Problem · 1

    PATIENT WAS PLAYING TENNIS AND WITH HER FOOT PLANTED, MADE A TWIST AND FELT THE SENSATION IN THE KNEE. AT SURGERY THE KRH FEMUR WAS FOUND TO BE LOOSE. THE GMRS PROX TIBIA WAS LOOSE. THE COMPONENTS WERE REPLACED WITH A SMALL GMRS DISTAL FEMUR AND A SMALL GMRS PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323602 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention