BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ORTHOPAEDICS SHAPEMATCH CUTTING GUIDE

    MDR report key: 4174337 · Received October 7, 2014

    Report

    Report Number
    MW5038580
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    April 5, 2013
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS EMAIL IS REGARDING THE STRYKER TRIATHLON SHAPEMATCH CUTTING GUIDE. MY TOTAL KNEE REPLACEMENT WAS ON (B)(6), 2013. THE SHAPEMATCH CUTTING GUIDE OFFICIAL RECALL WAS ON (B)(6), 2013. THE CEMENT BETWEEN THE STRYKER TRIATHLON KNEE IMPLANT AND MY FEMUR DID NOT BOND. I AM SCHEDULE FOR A REVISION SURGERY ON (B)(6), 2014. I HAVE READ MY SURGEON'S OPERATING NOTES. FROM THE CONTENT OF THESE NOTES, THERE IS NO WAY TO KNOW WHICH CUTTING GUIDE MY SURGEON USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629085 STRYKER ORTHOPAEDICS SHAPEMATCH CUTTING GUIDE SHAPEMATCH CUTTING GUIDE MBH STRYKER

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention