BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L

    MDR report key: 16021047 · Received December 21, 2022

    Report

    Report Number
    3005180920-2022-00959
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    December 5, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826771
    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 (B)(6) 2022: LOT 2002758: 100 ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2020. EXPIRATION DATE: 2025-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 68 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 INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY 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
    2024346 GMK-SPHERE 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0512FL 2002758 07630030826771

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention