BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ULTAMET METAL INSERT NEUT

    MDR report key: 3050113 · Received March 15, 2013

    Report

    Report Number
    MW5029664
    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) 2003. HE RECEIVED THE DEPUY TOTAL HIP PINNACLE ACETABULAR CUP 56 SZ MM, ULTAMET METAL INSERT NEUT 36MM 56D, AND THE S-ROM METAL ON METAL FEMORAL HEAD 36MM, +3 12/13 CONE. IN 2005, HE BEGAN HAVING SEVERE PAIN IN HIS LEFT FOOT AND HIP AND HIS LEFT HIP POPS WHEN HE MOVES. IN 2011, HIS BLOOD WAS TESTED AND HIGH LEVELS OF COBALT AND CHROMIUM WERE CONFIRMED. REASON FOR USE: AVASCULAR NECROSIS/OSTEOARTHRITIS OF LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110334 DEPUY ULTAMET METAL INSERT NEUT METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 121887356 1125641
    110362 DEPUY PINNACLE SECTOR 11 ACETABULAR CUP METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-22-056 X1EDD1016
    110363 DEPUY S-ROM METAL ON METAL FEMORAL HEAD METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1365-32-000 1097762

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S