BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE ACETABULAR CUP

    MDR report key: 3050191 · Received March 15, 2013

    Report

    Report Number
    MW5029674
    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) 2002. HE RECEIVED THE DEPUY TOTAL HIP PINNACLE ACETABULAR CUP SZ 56MM. HIS RECORDS FROM THIS SURGERY HAVE BEEN DISCARDED BY THE HOSPITAL, THEREFORE THE INFO FOR THE OTHER COMPONENTS IS NO LONGER AVAILABLE. IN 2010, HE BEGAN HAVING PAIN IN HIS LEFT LEG, HIP AND GROIN, MAKING IT DIFFICULT TO WALK OR PERFORM PHYSICAL ACTIVITY. THE PAIN HAS GRADUALLY WORSENED OVER THE PAST 2 YEARS. HE ALSO HAS A BURNING SENSATION IN HIS LEFT LEG AND POPPING SENSATION IN HIS LEFT HIP. DATES OF USE: LEFT HIP: (B)(6) 2002- PRESENT. REASON FOR USE: AVASCULAR NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110199 DEPUY PINNACLE ACETABULAR CUP METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC. 1217-03-056 UE6FDA004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S