BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT

    MDR report key: 6511303 · Received April 21, 2017

    Report

    Report Number
    3005180920-2017-00195
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    March 22, 2017
    Report Date
    April 21, 2017
    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 27 MARCH 2017 AND INCLUDES: THE PATIENT HAD AN INFECTION. THE PATHOGEN IS UNKNOWN. BATCH REVIEW PERFORMED ON 19 APRIL 2017. LOT 160049: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 2016. EXPIRATION DATE: 2021-04-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. AT FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD AN INFECTION, BUT THE PATHOGEN IS UNKNOWN. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292928 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 160049

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention