BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L

    MDR report key: 16633974 · Received March 29, 2023

    Report

    Report Number
    3005180920-2023-00204
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    February 27, 2023
    Report Date
    March 29, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826771
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 MARCH 2023. LOT 2100112: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-03-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953847 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L KNEE INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0512FL 2100112 07630030826771

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention