BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE SECTOR II CUP SIZE 52

    MDR report key: 1852931 · Received September 28, 2010

    Report

    Report Number
    MW5017643
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    May 24, 2007
    Report Date
    September 28, 2010
    Manufacturer
    DEPUY
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A (B)(6) FEMALE NURSE PRACTITIONER WHO HAD A LEFT TOTAL HIP REPLACEMENT ON (B)(6), 2007, DUE TO HIP DYSPLASIA RESULTING IN END STAGE OSTEOARTHRITIS. A DEPUY PINNACLE SECTOR II CUP SIZE 52 REPLACEMENT WITH A CORALL #12 HA COATED STEM AND HEAD -METAL ON METAL- WAS USED. AFTER APPROXIMATELY ONE YEAR, I DEVELOPED SIGNIFICANT DISCOMFORT -NO DISLOCATION- IN THE SAME HIP RESULTING IN THE NECESSITY OF A REVISION ON (B)(6), 2010. IN THE REVISION, A PINNACLE MARATHON LINER AND BIOLOX DELTA ARTICULES HEAD WERE USED. I HAVE THE OPERATING ROOM REPORTS OF EACH SURGERY. MY CONCERN IS THAT I STILL HAVE A CONSTANT ACHE IN THIS HIP, WORSENED WITH ACTIVITY TO THE POINT OF PREVENTING A LONG WALK. I'M AWARE OF THE DEPUY ASR RECALL. IS THERE ANY DATA REGARDING THE DEPUY PINNACLE? THESE SURGERIES HAVE BEEN VERY COSTLY. I BELIEVE MY ORTHOPEDIC SURGEON ACTED IN GOOD FAITH AND APPROPRIATELY BUT WITH FAULTY EQUIPMENT. DATES OF USE: (B)(6) 2007 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: HIP DYSPLASIA; END STAGE OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE SECTOR II CUP SIZE 52 NONE KWA DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability