BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1222226 · Received November 5, 2008

    Report

    Report Number
    MW5008898
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 24, 2008
    Manufacturer
    SMITH & NEPHEW
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FEMORAL COMPONENT (STEM) OF LEFT HIP PROSTHESIS BROKE INTO 2 PARTS. DATES OF USE: 2006 TO 2008. DIAGNOSIS OR REASON FOR USE: FAILED HIP FRAC REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FEMORAL COMPONENT (STEM) KWY SMITH & NEPHEW 71310412 80113234

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention