BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY I BCS/RENASY

    MDR report key: 3932989 · Received July 14, 2014

    Report

    Report Number
    1020279-2014-00422
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    July 6, 2012
    Report Date
    July 14, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS REPORTED DUE TO JOINT INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410681 JOURNEY I BCS/RENASY JOURNEY FEM OX NP BCS RT SZ 8 JWH SMITH & NEPHEW, INC. 10HM11289

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 74023271/ 09BM05392| 74024832/ 09GM07458| 74022217/ 10HM08397