BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1060222 · Received June 13, 2008

    Report

    Report Number
    3005477969-2008-00036
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 13, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD., UK
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY HAS BEEN PERFORMED FOLLOWING FUSION OF PT'S FEMUR TO PELVIS. THIS FUSION RESULTED IN THE BHR IMPLANTS BEING SURROUNDED IN BONE. RESULTING IN NO RANGE OF MOTION. THE SURGEON DOES NOT FAULT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR RESURFACING FEMORAL HEAD KWY SMITH & NEPHEW ORTHOPAEDICS LTD., UK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R BHR ACETABULAR CUP