BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11731092 · Received April 27, 2021

    Report

    Report Number
    3005180920-2021-00331
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 27, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    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 30 MARCH 2021: LOT 1900380: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2019. EXPIRATION DATE: 2024-04-21. 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 THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 10 MM INSERT WITH A 14MM ONE 1 YEAR AFTER PRIMARY TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628631 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM L TIBIAL INSERT FIXED FLEX JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 1900380 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention