BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22008319 · Received May 13, 2025

    Report

    Report Number
    3005180920-2025-00406
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 13, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819957
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 APRIL 2025: LOT 2210945: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27/09/2022. EXPIRATION DATE: 11/09/2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 22 APRIL 2025: GMK-SPHERIKA 02.12.E0610FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R E-CROSS (K202022) LOT 2316331: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13/07/2023. EXPIRATION DATE: 28/06/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA16R FEMORAL COMPONENT SPHERIKA CEMENTED S6+R (K211004) LOT 2317029: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03/11/2023. EXPIRATION DATE: 11/10/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE DUE TO THE DEVELOPMENT OF SCAR TISSUE. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON CLEANED OUT THE SCAR TISSUE AND REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184924 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 6 JWH MEDACTA INTERNATIONAL SA 02.07.1206R 2210945 07630030819957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention