BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM

    MDR report key: 2881717 · Received December 13, 2012

    Report

    Report Number
    MW5028240
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A TOTAL RIGHT HIP REPLACEMENT ON (B)(6) 2008. I RECEIVED THE DEPUY TOTAL HIP SYSTEM PINNACLE 100 ACETABULAR CUP SZ MM 56. I STARTED HAVING GROIN PAIN RADIATING INTO MY THIGH AND UP IN MY BUTTOCK IN (B)(6) 2010. BLOOD TESTS SHOWED I HAD METAL-ON-METAL SYNOVITIS DUE TO FAILURE OF THIS PRODUCT. I HAD A RIGHT HIP REVISION ON (B)(6) 2011 REQUIRING ADD'L HOSPITALIZATION AND PHYSICAL THERAPY. DATES OF USE: (B)(6) 2008-(B)(6) 2011. REASON FOR USE: RIGHT HIP OSTEOARTHROSIS. PHYSICAL THERAPY: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM METAL ON METAL HIP IMPLANTS, ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1217-01-056
    2 DEPUY APEX HOLE ELIMINATOR - PS METAL ON METAL HIP IMPLANT, HOLE ELIMINATOR JDI DEPUY ORTHOPAEDICS, INC. C4AAA1000
    3 DEPUY PINNACLE METAL INSERT METAL ON METAL HIP IMPLANT, METAL INSERT KWA DEPUY ORTHOPAEDICS, INC. 2719049
    4 DEPUY CORAIL METAL ON METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC. 2888203

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R