BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1321530 · Received February 12, 2009

    Report

    Report Number
    3005477969-2009-00014
    Event Type
    Injury
    Date Received
    February 12, 2009
    Date of Event
    December 4, 2008
    Report Date
    January 30, 2009
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD., U.K.
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE A MISMATCH IN HIP IMPLANT SIZES. THE PT WAS ORIGINALLY IMPLANTED WITH A BR FEMORAL HEAD (PACKAGED AS COLOR BROWN) WITH A 60MM ACETABULAR CUP (PACKAGED AS COLOR GREEN). THE PT WAS REVISED TO A ACETABULAR CUP (PACKAGED AS COLOR BROWN). THE SURGICAL TECHNIQUE CLEARLY STATES, "NEVER MIX COLORS ON HEADS AND CUPS. COMPATIBLE FEMORAL AND ACETABULAR COMPONENTS ARE ALL THE SAME COLOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP KWB SMITH & NEPHEW ORTHOPAEDICS LTD., U.K. NA 086149

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R 74122160 ACETABULAR CUP| 74121152 RESURFACING FEMORAL HEAD| LOT 08DW16616