BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM PRESS FIT FLUTED STEM

    MDR report key: 4013059 · Received August 15, 2014

    Report

    Report Number
    0002249697-2014-03098
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INCORRECT STEM SELECTION INVOLVING A GMRS STRAIGHT PRESS-FIT STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE REPORTED STEM PUSHING THROUGH THE FEMUR WAS DUE TO USER ERROR. THE SURGEON RESOLVED THE ISSUE BY REPLACING THE STRAIGHT STEM WITH A CURVED STEM. THE IFU WARNS THAT IMPROPER SELECTION, PLACEMENT, POSITIONING OR FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS. THE SURGICAL PROTOCOL INDICATES THE USE OF TEMPLATES TO DETERMINE THE STEM PROFILE AND SIZE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXPLANTED DEVICES LISTED IN THIS REPORT ARE: CAT 6481-2-110 MRH KNEE FEMORAL BUSHINGS X 2, LOT CODE LDG566; CAT 6481-2-120 MRH AXLE LOT CODE CTD2117; CAT 6481-2-130 MRHK BUMPER INSERT - NEUTRAL LOT CODE LDM387. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE NEW FEMORAL STEM INSERTED ON (B)(6) PUSHED THROUGH THE BACK OF THE FEMUR AND HAD TO BE REPLACED WITH A CURVED STEM. THE SURGEON DID NOT WANT TO CHANGE THE FEMORAL COMPONENT THAT WERE FRESHLY PUT IN ON THE (B)(6).

    Description of Event or Problem · 1

    DISTAL FEMORAL GMRS WAS REVISED AND SURGEON DECIDE TO REIMPLANT PROSTHESES THAT WERE IMPLANTED ON (B)(6) 2014. ONLY THE 2 BUSHINGS, BUMPER, AXLE AND PRESSFIT STEM WERE REPLACED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489581 12MM PRESS FIT FLUTED STEM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH 8L4032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention