BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATROLOC FEMORAL STEM WITHOUT LATERAL SHOULDER

    MDR report key: 1477342 · Received September 16, 2009

    Report

    Report Number
    MW5012745
    Event Type
    Injury
    Date Received
    September 16, 2009
    Date of Event
    September 6, 2009
    Report Date
    September 14, 2009
    Manufacturer
    WHITESIDE BIOMECHANICS (NOW SIGNAL MEDICAL CORP.)
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HER LEG GAVE-WAY WHILE IN A STORE. AN AMBULANCE TOOK HER TO A HOSPITAL, WHERE AN X-RAY REVEALED A FRACTURED HIP STEM. SURGERY WAS PERFORMED TO REPLACE THE FRACTURED COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATROLOC FEMORAL STEM WITHOUT LATERAL SHOULDER HIP STEM KWY WHITESIDE BIOMECHANICS (NOW SIGNAL MEDICAL CORP.) SIZE: R3S-200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention