BEUDAMED
    FDA Adverse Event Summary report: N

    GMK UC TIBIAL INSERT FIXED SIZE 3 / 12 MM

    MDR report key: 3140295 · Received May 24, 2013

    Report

    Report Number
    3006639916-2013-00053
    Date Received
    May 24, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDACTA INTL SA
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED SOME INSTABILITY OF HIS KNEE TWO YRS POST-OP. A REVISION SURGERY WAS NECESSARY. REF MFR REPORT # 3005180920-2013-00053.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231139 GMK UC TIBIAL INSERT FIXED SIZE 3 / 12 MM KNEE TIBIAL INSERT JWH MEDACTA INTL SA 092265

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention