BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2190023 · Received August 4, 2011

    Report

    Report Number
    3005477969-2011-00167
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    August 3, 2011
    Report Date
    October 26, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO POSITIONAL CHANGES OF THE ACETABULAR CUP. THE PATIENT REPORTED PAIN 2 WEEKS PRIOR TO REVISION. AT THE TIME OF REVISION, THE CUP WAS LOOSE AND REMOVED, ALONG WITH THE FEMORAL HEAD AND SLEEVE. THE FEMORAL STEM WAS WELL FIXED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 097315

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R FEMORAL HEAD, PART#74222154, LOT#9831| MODULAR SLEEVE, PART#74222200, LOT#08LW19881