BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESURFACING

    MDR report key: 4153036 · Received October 8, 2014

    Report

    Report Number
    1020279-2014-00627
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED. PATIENT WAS REVISED TO OVAL PATELLA AND CHANGED INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631780 RESURFACING JRNY BCS PAT RESRF RD 35 MM STD JWH SMITH & NEPHEW, INC. 10GM03356

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 74023263