BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM R

    MDR report key: 8757900 · Received July 3, 2019

    Report

    Report Number
    3005180920-2019-00528
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 3, 2019
    Report Date
    July 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 3 JULY 2019: LOT 172821: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2017. EXPIRATION DATE: 2022-06-23. 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

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 9 MONTHS AFTER THE PRIMARY DUE TO KNEE STIFFNESS. THE SURGEON REVISED THE 12MM POLY WITH A 10 MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553418 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM R KNEE TIBIAL INSERT FLEX JWH MEDACTA INTERNATIONAL SA 172821 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention