BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM

    MDR report key: 1012581 · Received March 12, 2008

    Report

    Report Number
    1020279-2008-00079
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 10, 2008
    Manufacturer
    SMITH & NEPHEW, INC./ORTHOPAEDIC DIV
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS REPORTED DUE TO DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM LINER KWB SMITH & NEPHEW, INC./ORTHOPAEDIC DIV NA 04CM08552R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| R HEAD- ITEM#: 7130220| STEM-ITEM#: 71306610