BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD CON DIST STEM 14 X 155 MM

    MDR report key: 1150516 · Received September 4, 2008

    Report

    Report Number
    9616680-2008-00268
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K013106
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 14MM STEM WAS PACKAGED IN THE 17MM BOX. SURGEON HAD TO REAM UP TO AN 18MM STEM. PATIENT'S DISTAL FEMUR FRACTURED UPON TRIAL REDUCTION. IT WAS FURTHER REPORTED THAT THE PATIENT DIED 2 DAYS POST OP. CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOD CON DIST STEM 14 X 155 MM IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA CAXHB18

    Patients

    Seq Age Sex Outcome Treatment
    1 106 YR Other