BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY INC.

    MDR report key: 377204 · Received February 11, 2002

    Report

    Report Number
    MW1024067
    Event Type
    Injury
    Date Received
    February 11, 2002
    Date of Event
    June 26, 2001
    Report Date
    February 11, 2002
    Manufacturer
    DEPUY INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1999 LEFT, THR WITH AN ALL-METAL ONE-PIECE "CUSTOM" CUP AND 36MM BLL. PART OF A "CUSTOM SERIES". IN 2000 LEFT GROIN PAIN. IN 2001, MIDDLE ANTERIOR THIGH PAIN. THE NEXT MONTH MASSIVE LEFT THIGH SWELLING. DIAGNOSIS WAS ACUTE NON-INFECTIOUS SYNOVITIS AND LEFT HIP WITH RUPTURE INTO ANTERIOR THIGH AND RESIDUAL LEFT ANTERIOR THIGH MASS. ETIOLOGY WAS "UNCERTAIN". TWO MONTHS LATER, LEFT HIP ARTHROSCOPY WITH DIAGNOSIS OF SYNOVITIS CAUSED BY MULTIPLE (60+) BEADS. WORSENING/CONSTANT LEFT LEG PAIN WITH MINIMAL/NO RELIEF FROM NSAIDS/NARCOTICS. THE NEXT MONTH SELF ADMISSION FOR LEFT HIP REDO. HCT 25.5 ESR 130 CRP 11.6. WARM AUTOANTIBODIES WITH INCOMPATIBILITY TO ALL DONOR BLOOD. FIVE DAYS LATER LEFT HIP REDO WITH REPLACEMENT OF CUP-WITH METAL/POLY AND BALL (32MM). TWO MONTHS LATER SERUM COBALT 18.3 NG/ML-NL <0.3-. TWO MONTHS OF INTENSIVE REHAB WITH DOCUMENTED UNRESOLVED SEVERE LEFT QUADRICEPS WASTING. EMG/NCT CONFIRMED "A SEVERE LEFT FEMORAL NEUROPATHY" WITH RECOVERY EXPECTED EXPECTED TO BE SLOW-1-2 YEARS AND PROBABLY INCOMPLETE. CURRENTLY, NORMAL PHYSICAL ACTIVITIES CONTINUE TO BE SEVERELY RESTRICTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY INC. CUSTOM METAL/METAL ONE-PIECE CUP KWB DEPUY INC. * S32GH1001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R| S