BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 9659602 · Received February 3, 2020

    Report

    Report Number
    3005180920-2020-00016
    Event Type
    Injury
    Date Received
    February 3, 2020
    Date of Event
    January 6, 2020
    Report Date
    February 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JANUARY 2020. LOT 172785: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2017. EXPIRATION DATE: 2022-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY AND SWELLING IN THE KNEE. THE CAUSE OF THE INSTABILITY AND SWELLING IS UNKNOWN. THE SURGEON REVISED THE POLY WITH A BIGGER ONE (14MM) ALMOST 2 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120645 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 172785 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention