BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS SBG

    MDR report key: 3748278 · Received April 14, 2014

    Report

    Report Number
    9613369-2014-00058
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    February 14, 2012
    Report Date
    April 6, 2014
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CLINICAL STUDY THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING / OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227118 PLUS SBG SBG STEM WITH HA, LEFT, SIZE 01, NON-CEMENTED. KWY SMITH&NEPHEW, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R PART: ASKU - METAL BALL HD, SIZE 32XL LOT NO: ASKU| PART: ASKU -STANDARD INLAY - LOT NO: ASKU