BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY HIP (PINNACLE)

    MDR report key: 1905843 · Received November 22, 2010

    Report

    Report Number
    MW5018265
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    August 1, 2007
    Report Date
    November 12, 2010
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DIAGNOSED WITH ARTHRITIS OF THE HIP AND HAD DEPUY HIP (PINNACLE) PLACED IN (B)(6) 2007 (R) HIP. SINCE HAVING PROSTHESIS, PT HAS EXPERIENCED DEBILITATING PAIN WHICH ULTIMATELY LED TO HER RETIREMENT AS A SCHOOL TEACHER. HAS HAD PAIN FOR 3 YEARS AS WELL AS CYST FORMATION IN HER GROIN AND ELEVATED COBALT AND CHROMIUM LEVELS. WELL AWARE OF THE RECENT RECALL FOR DEPUY'S ASR PROSTHESIS. THINKS SHE HAD REACTION TO METAL. ON (B)(6) 2010, HIP WAS REPLACED WITH A CERAMIC/POLY INSERT. STATES NOT ALL OF INITIAL HIP WAS REMOVED, THINKS JUST THE OUTER SHELL AND STEM WERE REPLACED. ALSO HAD (L) HIP REPLACED AT THIS TIME AS WELL DUE TO INCREASING ARTHRITIC PAIN. DATES OF USE: (B)(6) 2007 - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: ARTHRITIS HIP (PAIN). EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY HIP (PINNACLE) METAL ON METAL HIP REPLACEMENT SYSTEM LPH JOHNSON AND JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other