BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L

    MDR report key: 11931389 · Received June 3, 2021

    Report

    Report Number
    3005180920-2021-00467
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826818
    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 31-MAY-2021: LOT 2002760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2020. EXPIRATION DATE: 2025-03-29. 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 DUE TO SIGNS OF INFECTION 1 MONTH AFTER THE PRIMARY SURGERY, 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
    832538 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0514FL 2002760 07630030826818

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention