BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURDURT TS TIB INSMED 13MM

    MDR report key: 1000197 · Received February 19, 2008

    Report

    Report Number
    9616680-2008-00036
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    December 19, 2007
    Report Date
    January 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    HSH
    PMA / PMN Number
    K973164
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT WENT TO SEE THE DOCTOR IN 2007 COMPLAINING OF KNEE PAIN. AN X-RAY WAS TAKEN AND REVEALED THAT THE SCREW IN THE TIBIAL BASEPLATE/INSERT HAD SHEARED OFF. THE DOCTOR WAS ABLE TO REMOVE THE BROKEN PART OF THE SCREW AND IMPLANTED AN 11MM MED TS INSERT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURDURT TS TIB INSMED 13MM IMPLANT HSH STRYKER ORTHOPAEDICS CORK NA VSZAA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention