BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1863416 · Received October 11, 2010

    Report

    Report Number
    3005477969-2010-00169
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    February 15, 2010
    Report Date
    December 9, 2010
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED WERE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. AN INDEPENDENT RESEARCH FACILITY HAS PROVIDED A COPY OF THE REPORT TO THE MANUFACTURER, BUT THE DEVICES WILL NOT BE RETURNED. WE HAVE SELECTED EVALUATION CODES BASED ON THE AVAILABLE INFORMATION WITHIN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD A #6 REJUVENATE MONOLITHIC STEM IMPLANTED WITH A +5 -36MM V40 HEAD AND 54MM E SERIES TRITANIUM SHELL. FEMORAL STEM SUBSIDED AND PT COMPLAINED OF LEG LENGTH DISCREPANCY NO DISLOCATION OCCURRED PRIOR TO REVISION. SURGEON REVISED TO A 40MM LINER AND +12 -40MM HEAD TO GET BACK LENGTH. UPON RETRIEVAL SOME YELLOWING OF LINER WAS OBSERVED. HEAD AND LINER RETRIEVED FROM PRIMARY SURGERY ARE BEING SENT FOR ANALYSIS. STEM AND SHELL REMAINED IN PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR DYSPLASIA CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 32007 106

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R FEMORAL HEAD, PART#121446, LOT#35040| FEMORAL STEM, PART AND LOT# UNKNOWN