BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1140977 · Received August 28, 2008

    Report

    Report Number
    3005477969-2008-00049
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    May 1, 2008
    Report Date
    August 27, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD. UK
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOLLOWING A POSTERIOR COLUMN FRACTURE OF LEFT ACETABULUM. THE PT REPORTS THAT AT THE TIME OF REVISION THERE WAS AN ERODED PELVIS, METAL DEBRIS, STAINED TISSUE AND BONE AND 3 MONTHS POST-OPERATIVELY THE PT IS NON WEIGHT BEARING. PT HAD RECEIVED A CHIARI OSTEOTOMY PRIOR TO INITIAL IMPLANTATION OF BHR. IMPLANTING SURGEON NOTED. "PREVIOUS CHIARI-USELESS FOR CUP FIXATION".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R BHR FEMORAL HEAD