BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3010137 · Received March 19, 2013

    Report

    Report Number
    3005477969-2013-00089
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 12, 2013
    Report Date
    December 4, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT SHOULD BE NOTED THAT THE DEVICES REPORTEDLY IMPLANTED IN THIS EVENT WERE UTILIZED IN AN OFF-LABEL APPLICATION IN THE USA. THE BHR ACETABULAR CUP IS APPROVED FOR USE IN THE USA ONLY WITH A BHR RESURFACING FEMORAL HEAD. THE SMITH & NEPHEW HEMI-HEAD (LARGE DIAMETER COCR FEMORAL HEAD) IS ONLY FDA APPROVED FOR USE WHEN ATTACHED TO A SMITH & NEPHEW FEMORAL STEM FOR ARTICULATION ON NATIVE BONE, NOT ON AN ACETABULAR COMPONENT (SUCH AS A BHR ACETABULAR CUP).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO RIGHT HIP PAIN, DECREASED FUNCTION, WEAKNESS OF THE LEGS AND HIPS, AND AN ADVERSE REACTION TO METAL DEBRIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS SCHEDULED TO BE PERFORMED IN TWO WEEKS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113665 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 084332

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R FEMORAL STEM, PART# 71306113, LOT 08EM20007| FEMORAL HEAD, PART AND LOT# UNKNOWN| HEMI HEAD, PART# 74122546, LOT 08EW17108| MODULAR SLEEVE, PART# 74222200, LOT 07LW14957