BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2830976 · Received November 14, 2012

    Report

    Report Number
    3005477969-2012-00375
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 10, 2011
    Report Date
    November 21, 2012
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD 52199 064

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R FEMORAL HEAD, PART#74121146, LOT -4 055 (PARTIAL)| FEMORAL HEAD, PART #74121146, LOT UNKNOWN