BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE 300 ACETABULAR CUP

    MDR report key: 3050179 · Received March 15, 2013

    Report

    Report Number
    MW5029669
    Event Type
    Injury
    Date Received
    March 15, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2007. SHE RECEIVED THE DEPUY TOTAL HIP PINNACLE 300 ACETABULAR CUP SZ MM 54, THE PINNACLE METAL INSERT 36MMID X 54MMOD, AND THE ARTICUL/EZE METAL ON METAL FEMORAL HEAD 036MM +5 12/14 CONE. SINCE THE BEGINNING OF 2011, HER LEFT HIP HAS FELT LIKE IT IS GOING TO LOCK UP OR POP OUT. SHE HAS SEVERE PAIN IN HER LEFT HIP RADIATING DOWN TO HER KNEE. WHEN SHE IS ON HER FEET A LOT, SHE CAN FEEL THE IMPLANT MOVING. IF SHE WALKS TOO MUCH, HER LEFT LEG DRAGS. SHE ALSO HAS METALLOSIS DUE TO ELEVATED COBALT AND CHROMIUM LEVELS IN HER BLOOD. REASON FOR USE: DEGENERATIVE ARTHRITIS OF LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110157 DEPUY PINNACLE 300 ACETABULAR CUP METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-03-054 BE2EX1000
    110183 DEPUY PINNACLE METAL INSERT METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 121887354 2334987
    110184 DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1365-52-000 2346513

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S