BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/20 MM R

    MDR report key: 12505060 · Received September 21, 2021

    Report

    Report Number
    3005180920-2021-00769
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    August 27, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826702
    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 SEPTEMBER 2021. LOT 2002799: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-APR-2020. EXPIRATION DATE: 2025-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 2 WEEKS AFTER THE PREVIOUS REVISION SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402507 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/20 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0420FR 2002799 07630030826702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention