BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L E-CROSS

    MDR report key: 13504883 · Received February 10, 2022

    Report

    Report Number
    3005180920-2022-00118
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    January 20, 2022
    Report Date
    February 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261914
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JANUARY 2022: LOT 2002484: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JULY-2020. EXPIRATION DATE: 2025-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988), LOT. 2009482. BATCH REVIEW PERFORMED ON 27 JANUARY 2022: LOT 2009482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-DEC-2020. EXPIRATION DATE: 2025-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0006L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L (K121416), LOT. 2100338. BATCH REVIEW PERFORMED ON 27 JANUARY 2022. LOT 2100338: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-APR-2021. EXPIRATION DATE: 2026-03-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 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
    71233 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L E-CROSS KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.E0414FL 2002484 07630971261914

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention