BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DE PUY

    MDR report key: 771183 · Received October 10, 2006

    Report

    Report Number
    771183
    Event Type
    Injury
    Date Received
    October 10, 2006
    Date of Event
    September 13, 2006
    Report Date
    September 15, 2006
    Manufacturer
    DE PUY
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD REPEATED EPISODES OF DISLOCATION. LEFT HIP WAS ORIGINALLY PLACED IN 2002 - AT ANOTHER HOSP. ORIGINAL SURGERY INVOLVED - DEPUY PINNACLE ACETABULAR CUP WITH NO HOLES (54 MM OUTER DIAMETER). APEX HOLE ELIMINATOR X 1, DEPUY SUMMIT SIZE 5 TAPERED HIP WITH PORTOCOAT. +4 MM 10-DEGREE ELEVATED ACTABULAR LINER, 28-MM, +5 NECK LENGTH FEMORAL HEAD. LINER AND HEAD WERE REMOVE/REPLACED IN 2006. IN ACCORDANCE WITH HOSP POLICY THE COMPONENTS REMOVED ARE NOT AVAILABLE FOR RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DE PUY LEFT HIP COMPONENTS-LINER AND HEAD KWB DE PUY NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention