BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6503409 · Received April 19, 2017

    Report

    Report Number
    3005180920-2017-00186
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    March 20, 2017
    Report Date
    April 19, 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 21 MARCH 2017 AND INCLUDES: THE CASE HAS BEEN CANCELLED. THE PATIENT HAS BEEN TRANSFERRED TO ANOTHER CLINIC. A REVISION DATE HAS NOT BEEN SCHEDULED YET. BATCH REVIEW PERFORMED ON 19 APRIL 2017. LOT 162638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JULY 2016. EXPIRATION DATE: 2021-07-14. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PLANS TO REVISE THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285345 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 162638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention