BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE ALTRX NEUTRAL

    MDR report key: 3042778 · Received April 4, 2013

    Report

    Report Number
    MW5029651
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    June 20, 2011
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, I HAD TO HAVE MY RIGHT HIP REPLACED DUE TO METAL ON METAL BREAKDOWN. I HAD HIGH LEVELS OF COBALT 60.3 AND CHROMIUM 34.1. AFTER THIS SURGERY, I WAS STILL IN EXTREME PAIN. I HAD DIFFICULTY WALKING, STANDING, BENDING, AND GETTING UP AND DOWN FROM THE FLOOR. I WENT TO MY SURGEON. HE SAID THAT IT MAY TAKE ME LONGER TO HEAL DUE TO THE METALLOSIS IN MY HIP. THE PAIN BECAME SO BAD THAT I SOUGHT TREATMENT FROM A DIFFERENT DOCTOR. HE DID AN MRI WHICH SHOWED A POCKET OF FLUID. HE SUGGESTED SURGERY. ON (B)(6) 2012, I HAD A RIGHT HIP REVISION OF THE FEMORAL HEAD AND THE ACETABULAR INSERT. FLUID TAKEN FROM MY HIP, DURING THIS SURGERY, WAS FOUND TO HAVE PROPIONIBACTERIUM INFECTION. SAME PT AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138297 DEPUY PINNACLE ALTRX NEUTRAL HIP IMPLANT LPH DEPUY ORTHOPAEDICS, INC 1221-36-456 ED9SJ1000
    138298 ARTICUL/EZE METAL ON METAL FEMORAL HEAD FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC 1365-51-000 3300426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O| R| S