BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2112628 · Received May 19, 2011

    Report

    Report Number
    1818910-2011-08573
    Event Type
    Injury
    Date Received
    May 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    DEPUY INTL. LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: ON OR ABOUT (B)(6) 2008, PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: CLICKING AND POPPING OF THE ASR IMPLANT; PERSISTENT SEVERE PAIN AND DISCOMFORT IN HER HIP, GROIN, BUTTOCKS AND LEGS; SUDDEN SEVERE PAIN WHEN WALKING OR STANDING, SENSATION OF MISALIGNMENT, WEAKNESS, AND DECREASED RANGE OF MOTION. IT IS DIFFICULT FOR THE PT TO WALK, MOVE HER LEGS, AMBULATE, OR ENGAGE IN MOST ACTIVITIES OF DAILY LIVING. PHYSICIANS EXAMINED, TESTED, AND ADVISED PT THAT SHE SUFFERS FROM SUBSTANTIALLY ELEVATED, NOT TOXIC, COBALT AND CHROMIUM METAL IONS IN HER BLOOD STREAM. HER FIRST BLOOD TEST IN (B)(6) 2009 REVEALED LEVELS OF COBALT AT 8.9 AND CHROMIUM AT 4.2; HER MOST RECENT BLOOD TEST IN (B)(6) 2011 REVEALED COBALT LEVELS AT 21.9 AND CHROMIUM LEVELS AT 4.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP TOTAL HIP REPLACEMENT KWA DEPUY INTL. LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention