BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L

    MDR report key: 15734460 · Received November 4, 2022

    Report

    Report Number
    3005180920-2022-00806
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 5, 2022
    Report Date
    November 4, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 OCTOBER 2022: LOT 2201039: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2022. EXPIRATION DATE: 2027-02-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 MONTHS FROM SURGERY 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
    2528904 GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 2201039 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention