BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3954256 · Received July 24, 2014

    Report

    Report Number
    3005477969-2014-00418
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    March 24, 2013
    Report Date
    July 31, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION SUPPLIED, THIS PATIENT WAS IMPLANTED WITH MIS-MATCHED FEMORAL HEAD (LABEL COLOUR CODED RED) AND ACETABULAR COMPONENT (LABEL COLOUR CODED GREY). THE LABEL COLOUR MATCHING OF BHR IMPLANTS IS COVERED WITHIN THE BHR SURGICAL TECHNIQUE AND SURGEON TRAINING. LABEL COLOURS ON HEADS AND ACETABULAR CUPS ARE NEVER TO BE MIXED. COMPATIBLE FEMORAL AND ACETABULAR COMPONENTS ARE ALL THE SAME COLOUR. IN THIS CASE, MIS-MATCH OF DEVICES HAS CONTRIBUTED TO THE NEED FOR REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF THE IMPLANT STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433270 BHR FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS LTD 076316

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R ACETABULAR CUP, PART #74122156 AND LOT #8988