BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE ULTAMET METAL INSERT

    MDR report key: 3246477 · Received July 8, 2013

    Report

    Report Number
    3246477
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 26, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    REVISION OF L THA (FEMORAL COMPONENT) WITH POLY EXCHANGE (ADDED 10DEG ANTEVERSION). PROCEDURE REVEALED ACETABULAR COMPONENT IN POSITION OF RELATIVE RETROVERSION, BUT WELL FIXED. LOOSE ACETABULAR COMPONENT. REVISED LOOSE FEMORAL COMPONENT AND EXCHANGED POLY FOR ADDITIONAL 10 DEGREES OF ANTEVERSION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REVISION OF L THA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #4IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #5IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312118 PINNACLE ULTAMET METAL INSERT PROSTHESIS, HIP, KWA DEPUY ORTHOPAEDICS * 1965131
    312119 PINNACLE POROCOAT SECTOR SHELL PROSTHESIS, HIP KWA DEPUY ORTHOPAEDICS * Z5WAS1000
    312120 S-ROM M HEAD PROSTHESIS, HIP LPH DEPUY ORTHOPAEDICS * 1981389
    312328 S ROM ZTT PROXIMAL FEMORAL SLEEVE PROSTHESIS, HIP LPH DEPUY ORTHOPAEDICS * 1944697
    312329 SROM FEMORAL STEM STANDARD PROSTHESIS, HIP KWA DEPUY ORTHOPAEDICS * 1965262

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR