BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE 300 ACETABULAR CUP

    MDR report key: 3050184 · Received March 15, 2013

    Report

    Report Number
    MW5029671
    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 52, THE PINNACLE METAL INSERT 36MMX52MMOD, AND THE ARICUL/EZE METAL ON METAL FEMORAL HEAD 36MM, -2, 12/14 CONE. IN 2010 SHE BEGAN EXPERIENCING PAIN AND A BURNING SENSATION IN HER LEFT HIP ON A DAILY BASIS. SHE IS UNABLE TO STOOP OR BEND OVER AND HER LEFT LEG GETS NUMB AT TIMES. THE PAIN AND BURNING HAS CAUSED HER HIP TO GIVE OUT, AND SHE HAS FALLEN SEVERAL TIMES AS A RESULT. THESE PROBLEMS ARE ONGOING. REASON FOR USE: AVASCULAR NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110657 DEPUY PINNACLE 300 ACETABULAR CUP METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS INC 1217-03-052 AB4H5A000
    110768 DEPUY PINNACLE METAL INSERT METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS INC 121887352 2234513
    110769 DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS INC 1365-50-000 2250328

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S