BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1813614 · Received August 25, 2010

    Report

    Report Number
    3005477969-2010-00107
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    May 28, 2010
    Report Date
    August 25, 2010
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CATALOG NUMBERS REPORTEDLY INVOLVED, 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 MAY HAVE CONTRIBUTED TO THE NEED FOR REVISION SURGERY. RELATED EVENT FOR THIS PATIENT WAS ALSO REPORTED UNDER MDR 3005477969-2010-00106.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE PATIENT HAD BEEN IMPLANTED WITH A FEMORAL HEAD (COLOR CODED RED) AND ACETABULAR CUP (COLOR CODED GREY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL STEM, PART#71356011, LOT UNKNOWN| FEMORAL HEAD, PART #74222150, LOT UNKNOWN| MODULAR SLEEVE, PART#74222100, LOT UNKNOWN