BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3231257 · Received July 17, 2013

    Report

    Report Number
    3005477969-2013-00295
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 17, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL ALSO SUBMITTED MDR UNDER USER FACILITY REPORT NUMBER: (B)(4). THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT WERE IMPLANTED IN AN OFF-LABEL APPLICATION IN THE USA, AS THE BHR ACETABULAR CUP IS FDA APPROVED FOR US ONLY WITH A BHR RESURFACING FEMORAL HEAD. THE HEMI-HEAD REPORTEDLY INVOLVED IS ONLY APPROVED FOR USE IN THE USA WHEN ATTACHED TO A SMITH & NEPHEW FEMORAL STEM FOR ARTICULATION ON NATIVE BONE, NOT ON AN ACETABULAR COMPONENT (BHR ACETABULAR CUP).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE DEVICES INVOLVED WERE REPORTEDLY IMPLANTED IN (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332249 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 72318

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R FEMORAL HEAD PART # 74122538, LOT# 10576| FEMORAL STEM, PART #71341022, LOT# 06EM04873