BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 17442776 · Received August 2, 2023

    Report

    Report Number
    3005180920-2023-00597
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 2, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 JULY 2023: LOT 2216381: (B)(4) MANUFACTURED AND RELEASED ON 4-NOV-2022. EXPIRATION DATE: 2027-10-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0024R FEMORAL COMPONENT SPHERE. CEMENTED SIZE 4+ R (K140826), LOT 2202831: (B)(4) MANUFACTURED AND RELEASED ON 02-MAY-2022. EXPIRATION DATE: 2027-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0411FR TIBIAL INSERT FIXED SPHERE. FLEX SIZE 4/11 MM R (K140826), LOT 2100100: (B)(4) MANUFACTURED AND RELEASED ON 06-APR-2021. EXPIRATION DATE: 2026-03-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 4 MONTHS POST-PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740797 GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 2216381 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention