BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11548805 · Received March 23, 2021

    Report

    Report Number
    3005180920-2021-00229
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826573
    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 08-MAR-2021. LOT 163055: 50 ITEMS MANUFACTURED AND RELEASED ON 4-AUG-2016. EXPIRATION DATE: 2021-JUL-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 4 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT TO A THICKER INSERT TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453436 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0412FL 163055 07630030826573

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention