BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY METAL INSERT

    MDR report key: 3050209 · Received March 15, 2013

    Report

    Report Number
    MW5029673
    Event Type
    Injury
    Date Received
    March 15, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    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 ACETABULAR CUP, SZ MM 52; METAL INSERT 36MM X52D, AND METAL ON METAL FEMORAL HEAD 36MM +1.5. SHE RECENTLY BEGAN HAVING PERSISTENT PAIN, POPPING AND A GRINDING SENSATION IN HER LEFT HIP, RADIATING INTO HER LEFT LEG. THIS PAIN CONTINUES TO WORSEN AND INTERFERES WITH HER DAILY LIFE. THE PAIN IS SO DEBILITATING THAT SHE CANNOT CARRY ON A DAILY ROUTINE AND HER LIMITED MOBILITY AND THE THOUGHT OF A REVISION SURGERY HAS CAUSED HER ANXIETY AND DEPRESSION TO WORSEN. THESE PROBLEMS ARE ONGOING. DATES OF USE: LEFT- (B)(6) 2007- PRESENT. REASON FOR USE: NONUNION OF LEFT FEMORAL NECK FRACTURE WITH BROKEN INTERNAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110658 DEPUY METAL INSERT METAL ON METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS 121887352 2151732
    110659 DEPUY METAL ON METAL FEMORAL HEAD METAL- ON -METAL HIP IMPLANT KWY DEPUY ORTHOPAEDICS 1365-51-000 2351956
    110781 DEPUY PINNACLE ACETABULAR CUP METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-22-052 BB1EY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S