BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2971274 · Received April 16, 2008

    Report

    Report Number
    3005477969-2008-00025
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 16, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD. U.K
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED. ACETABULAR COMPONENT WAS LOOSE AND MIGRATED TO VERTICAL POSITION, WHICH CAUSED THE PT PAIN AND POPPING IN THE HIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R REVISED TO 50MM DYSPLASIA CUP WITH 2 SCREWS| COUMADIN| PERCOCET| CELEBREX| (46MM & 40MM) FOR SUPERIOR FIXATION