BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC PLUS

    MDR report key: 1520614 · Received November 2, 2009

    Report

    Report Number
    9613369-2009-00158
    Event Type
    Injury
    Date Received
    November 2, 2009
    Report Date
    November 2, 2009
    Manufacturer
    AARAU SWITZERLAND MANUFACTURING SITE
    Product Code
    KRP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO SMITH & NEPHEW ORTHOPAEDICS THAT A REVISION SURGERY WAS PERFORMED IN A FOREIGN COUNTRY, DUE TO INSTABILITY. THE REVISION OCCURRED APPROXIMATELY 3-12 MONTHS AFTER IMPLANTATION. THIS IS ALL OF THE INFO THAT HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC PLUS FEMORAL/TIBIAL / KRP KRP AARAU SWITZERLAND MANUFACTURING SITE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R