BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE MULTIHOLE 11 ACETABULAR CUP

    MDR report key: 3050138 · Received March 15, 2013

    Report

    Report Number
    MW5029666
    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) 2010 REQUIRING REVISION SURGERY ON (B)(6) 2012. HE RECEIVED THE DEPUY TOTAL HIP PINNACLE MULTIHOLE 11 ACETABULAR CUP SZ MM 54, THE ARTICUL/EZE METAL ON METAL FEMORAL HEAD 36MM +1.5 12/14 TAPER, AND THE PINNACLE METAL INSERT 36MMID X 54MMOD. IN 2011, HE BEGAN HAVING PAIN IN HIS LEFT HIP AND LEG MAKING IT DIFFICULT TO WALK OR PERFORM PHYSICAL ACTIVITY. BY 2012 THE PAIN WAS SO SEVERE THAT IT INTERFERED WITH MY DAILY LIFE AND LIMITED MY MOBILITY. THE PAIN BECAME SO SEVERE THAT A REVISION WAS REQUIRED. HE CONTINUES TO SUFFER FROM PAIN RELATED TO THE RECOVERY FROM HIS REVISION SURGERY. REASON FOR USE: ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110221 DEPUY PINNACLE MULTIHOLE 11 ACETABULAR CUP METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-20-054 EH5DX1000
    110222 DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1365-51-00 3082741
    110338 DEPUY PINNACLE METAL INSERT METAL-ON-METAL HIP IMPLANT LPH DEPUY ORTHOPAEDICS, INC 1218-87-354 3072182

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S