BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 16435559 · Received February 24, 2023

    Report

    Report Number
    3005180920-2023-00110
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 24, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    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 07 FEBRUARY 2023. LOT: 2214129: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2022. EXPIRATION DATE: 2027-09-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: ONE MONTH AFTER PRIMARY TKA, EARLY INFECTION DEVELOPS AND IT IS NECESSARY TO REMOVE ALL IMPLANTS. INFECTIONS ARE A POSSIBLE ADVERSE EVENT FOLLOWING TKA, MENTIONED IN THE RELEVANT LITERATURE, AND THERE IS NO REASON TO SUSPECT THAT THE DEVFICES USED CAN BE HELD RESPONSIBLE FOR THE EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: REVISION SURGERY PERFORMED ABOUT 1 MONTH AFTER THE PRIMARY SURGERY DUE TO AN INFECTION. THE PICTURES AT HAND SHOW THE FEMORAL COMPONENT AND THE TIBIAL TRAY COVERED BY BIOLOGICAL FLUIDS AND CEMENT, AS EXPECTED AFTER IMPLANT REMOVAL. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO STATE ANY IMPLANT RELATED FAILURE ROOT CAUSE. ADDITIONAL INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON 07 FEBRUARY 2023 ON GMK-PRIMARY 02.12.0212CRR TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R (K181635) LOT: 2102133, LOT: 2102133: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2021. EXPIRATION DATE: 2026-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 07 FEBRUARY 2023 ON GMK-PRIMARY 02.12.0021R FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R (K140826) LOT: 163344C, LOT: 163344C: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2021. EXPIRATION DATE: 2026-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY (B)(4) ITEM INVOLVED IN THE COMPLAINT HAS BEEN SOLD. LOT: 163344: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JULY-2016. EXPIRATION DATE: 2021-07-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO INFECTION. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL COMPONENT, TIBIA AND INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935359 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1202R 2214129 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention