BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON & JOHNSON DEPUY

    MDR report key: 2004002 · Received February 23, 2011

    Report

    Report Number
    MW5019560
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    March 27, 2010
    Report Date
    February 23, 2011
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BILATERAL TOTAL HIP REPLACEMENTS USING THE DEPUY PINNACLE ULTAMET SYSTEM. I HAVE HAD PAIN SINCE I WOKE UP IN THE POST-OP 2003-2004. HAD REVISION DONE ON (B)(6) 2010. HAD A SEVERE INFLAMMATORY RESPONSE IN THE RIGHT HIP. WAS DIAGNOSED WITH VANCOMYCIN RESISTANT ENTEROCOCCUS AND (B)(6). HAD 2 MORE REVISIONS WITH A FINAL RE-IMPLANTATION OF THE RIGHT HIP WITH PINNACLE ULTAMET SYSTEM. LARGE SOFT TISSUE MASS OR FLUID AROUND THE RIGHT HIP ON INDIUM SCAN SLIGHT UPTAKE IN THE SUPERIOR ACETABULAR. INCREASED SED-RATE AND C-REACTIVE PROTEIN WITH NEGATIVE HIP ASPIRATION. INTRAOPERATIVE TISSUE SAMPLES CONSISTENT WITH METALLOSIS. COBALT LEVELS INCREASED. NOW FACING BILATERAL HIP REVISIONS DUE TO COBALTISM AND METALLOSIS. I HAVE HAD PAIN, STIFFNESS, CLUNKING AND SUBLUXATIONS, FEVER, TINNITUS, COGNITIVE DYSFUNCTION, RASH ON BOTH HANDS, FLUSHING, CHEST PAIN AND SHORTNESS OF BREATH, VERTIGO, LOSS OF HEARING AND BALANCE PROBLEMS. THERE NEEDS TO BE A RECALL. I AM PHYSICIAN'S ASSISTANT WITH 12 YRS ORTHOPEDIC SURGERY AND LOGGED THOUSANDS OF TOTAL ARTHROPLASTY CASES AND THE PINNACLE HAS A DESIGN FLAW WITH LOW NECK CLEARANCE CAUSING IMPINGEMENT AND EXCESSIVE WEAR. THE PINNACLE HIP SHOULD BE RECALLED. INPATIENT REHAB, OUTPATIENT PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON & JOHNSON DEPUY PINNACLE ACETABULAR, ULTAMET KWA JOHNSON AND JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R| S