BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX #3/10 MM RIGHT

    MDR report key: 5916991 · Received August 31, 2016

    Report

    Report Number
    3005180920-2016-00439
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    July 29, 2016
    Report Date
    August 31, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 08 AUGUST 2016 AND INCLUDES: THE PATIENT TESTED POSITIVE TO ALPHA DEFENSIN & SYNOVASURE (THE SYNOVASURE PJI TEST IS A TEST SPECIFICALLY DESIGNED AND VALIDATED FOR THE DIAGNOSIS OF PERIPROSTHETIC JOINT INFECTION - PJI). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. CULTURES WERE TAKEN. THE PATHOGEN IS UNKNOWN AT THIS TIME. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS AND X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569421 GMK-SPHERE TIBIAL INSERT FIXED FLEX #3/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 144276

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention