BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22328100 · Received June 25, 2025

    Report

    Report Number
    3005180920-2025-00602
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JUNE 2025: LOT 189147: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2019. EXPIRATION DATE: 2024-02-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 17 JUNE 2025: GMK-SPHERE 02.12.0023R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R (K140826) LOT 1810113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2019. EXPIRATION DATE: 2024-01-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0312CRR TIBIAL INSERT FIXED SPHERE CR SIZE 3/12 MM R (K181635) LOT 185617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2018. EXPIRATION DATE: 2023-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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

    AT ABOUT 6 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE TIBIAL COMPONENTS FAILED INTO VARUS. UPON REVISING THE PATIENT, THE SURGEON ALSO OBSERVED THAT THE FEMORAL COMPONENT WAS LOOSE. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359991 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 3 JWH MEDACTA INTERNATIONAL SA 02.07.1203R 189147 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention