BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIGHT MEDICAL TECHNOLOGIES SIZE 54MM QUADRANT LINEAGE ACETABULAR COMPONENT

    MDR report key: 2922364 · Received January 16, 2013

    Report

    Report Number
    MW5028645
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    November 18, 2008
    Report Date
    January 10, 2013
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MAN WITH END STAGE ARTHROSIS OF THE LEFT HIP UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. THE HIP STEM BROKE 2.8 YEARS LATER REQUIRING A SURGICAL REVISION. WRIGHT MEDICAL TECHNOLOGIES SIZE 54MM QUADRANT LINEAGE ACETABULAR COMPONENT WITH A GROUP II 32MM ID ALUMINA CERAMIC ACETABULAR LINER AND A PROFEMUR RENAISSANCE SIZE 12 S FEMORAL COMPONENT WITH A LONG VARUS NECK AND A 32X +5 ALUMINA CERAMIC FEMORAL HEAD COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24285 WRIGHT MEDICAL TECHNOLOGIES SIZE 54MM QUADRANT LINEAGE ACETABULAR COMPONENT ARTIFICAL HIP IMPLANT- ACETABULAR COMPONENT KWA WRIGHT MEDICAL
    24286 WRIGHT MEDICAL TECHNOLOGIES GROUP II 32MM ID ALUMINA CERAMIC ACETABULAR LINER ARTIFICIAL HIP IMPLANT - ACETABULAR LINER LZO WRIGHT MEDICAL
    24287 WRIGHT MEDICAL TECHNOLOGIES PROFEMUR RENAISSANCE 12 S FEMORAL COMPONENT W/LONG V ARTIFICIAL HIP IMPLANT- FEMORAL COMPONENT KWA WRIGHT MEDICAL
    24288 WRIGHT MEDICAL TECHNOLOGIES 32X +5 ALUMINA CERAMIC FEMORAL HEAD COMPONENT ARTIFICAL HIP IMPLANT - FEMORAL HEAD LZO WRIGHT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention