BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1811553 · Received August 23, 2010

    Report

    Report Number
    3005477969-2010-00103
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    February 18, 2010
    Report Date
    April 1, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. PATIENT HAD BEEN IMPLANTED FOR APPROXIMATELY 2 YEARS PRIOR TO REVISION. SURGEON REPORTED ALVAL AND METALLOSIS AT TIME OF REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 07KW14409

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R MODULAR SLEEVE, PART#74222200, LOT# 08BW15726| FEMORAL HEAD, PART #74222144, LOT #08AW15372 031| FEMORAL STEM, PART#71357005, LOT#07GM11243A