BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FLEX TIBIAL INSERT SIZE 4 L - 14 MM

    MDR report key: 3913854 · Received June 10, 2014

    Report

    Report Number
    3006639916-2014-00069
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS COMPLAINING OF PAIN AND THE SURGEON CONCLUDED THERE COULD BE A POTENTIAL INFECTION. THE SURGEON DID IRRIGATION AND DEBRIDEMENT OF THE AREA AND REPLACED THE POLY INSERT. REF MFR # 3005180920-2014-00069.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337479 GMK SPHERE FLEX TIBIAL INSERT SIZE 4 L - 14 MM FLEX KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 132007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention