BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE ACETABULAR CUP SYSTEM SZ 54

    MDR report key: 2961789 · Received February 11, 2013

    Report

    Report Number
    MW5028960
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    September 5, 2003
    Report Date
    January 10, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(6) HAD A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2003. (B)(6) RECEIVED THE DEPUY TOTAL HIP PINNACLE SECTOR II ACETABULAR CIP SZ 54, DEPUY S-ROM SIZE 13 STEM, SZ 18B SMALL PROXIMAL METAPHYSEAL PORTION, STANDARD NECK SZ 0 + 36 HEAD. PRIOR TO THE SURGERY, (B)(6) HAD INCREASING PAIN AND DISABILITY IN THE RIGHT HIP DUE TO DEGENERATIVE ARTHRITIS OF THE RIGHT HIP. IN (B)(6) 2010, (B)(6) BEGAN TO EXPERIENCE CHRONIC RIGHT HIP PAIN. ON (B)(6) 2010, (B)(6)'S CHROMIUM AND COBALT LEVELS WERE ELEVATED WITH CHROMIUM AT 1.3 AND COBALT AT 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60042 DEPUY PINNACLE ACETABULAR CUP SYSTEM SZ 54 HIP IMPLANT CUP KWA DEPUY ORTHOPAEDICS, INC. XV6EW1006
    60043 DEPUY S-ROM SIZE 13 STEM HIP IMPLANT STEM KWY DEPUY ORTHOPAEDICS, INC.
    60044 SZ 186 SMALL PROXIMAL METAPHYSEAL PORTION HIP IMPLANT KWY DEPUY ORTHOPAEDICS, INC.
    60045 36 HEAD HIP IMPLANT HEAD KXA DEPUY ORTHOPAEDICS, INC.
    60147 STANDARD NCK SZ 0 HIP IMPLANT NECK KWY DEPUY ORTHOPAEDICS, INC.

    Patients

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