BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE SECTOR II ACETABULAR CUP SIZE 54/MM

    MDR report key: 1950630 · Received December 29, 2010

    Report

    Report Number
    MW5018767
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    October 3, 2008
    Report Date
    December 29, 2010
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A DEPUY PINNACLE HIP IMPLANT IN (B)(6) 2005. AFTER REHAB FOLLOWING THE SURGERY, THE IMPLANT CAUSED MILD TO MODERATE PAIN OVER THE NEXT 2.5 YEARS. IN (B)(6) OF 2008, I AWOKE ONE MORNING WITH ACUTE PAIN IN MY RIGHT HIP AND THIGH. I WENT TO THE ER AND WAS X-RAYED, CT SCANNED, BOTH SHOWED NO ABNORMALITIES, GIVEN PAIN MEDICATION AND SENT HOME. THE PAIN SUBSIDED AFTER 2-3 DAYS. APPROXIMATELY 6 MONTHS LATER, (B)(6), 2008, THE ACUTE PAIN CAME BACK. WENT TO ER MRI SHOWED MILD INFLAMMATION, GIVEN PAIN MEDICATION AND SENT HOME. THIS TIME, THE PAIN DID NOT GO AWAY AND I WAS HOSPITALIZED IN (B)(6), 4 DAYS LATER. IT WAS DETERMINED THAT THE DEPUY PINNACLE HIP THAT HAD BEEN PUT IN WAS INFECTED. THREE TO FOUR SURGERIES WERE PERFORMED IN AN EFFORT TO SAVE THE HIP. IT WAS DETERMINED THAT THE HIP COULD NOT BE SAVED. I WENT TO A SPECIALIST IN (B)(6), THAT REMOVED THE DEPUY PROSTHESIS. SIX WEEKS WITHOUT A HIP AND ON IV ANTIBIOTIC THERAPY FOLLOWED. AFTER SIX WEEKS, A NEW PROSTHESIS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE SECTOR II ACETABULAR CUP SIZE 54/MM DEPUY PINNACLE HIP PROSTHESIS LPH JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R| S