BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 02.07.0220SCF FIXED TIBIAL INSERT SC SIZE 2/20MM

    MDR report key: 13505752 · Received February 10, 2022

    Report

    Report Number
    3005180920-2022-00074
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    August 16, 2021
    Report Date
    March 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816932
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JANUARY 2022: LOT 177655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-DEC-2017. EXPIRATION DATE: 2022-NOV-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 14 JANUARY 2022: GMK-SPHERE 02.12.0220FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/20 MM R (K121416) LOT 1811486: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2019. EXPIRATION DATE: 2024-MAR-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT 1908699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2019. EXPIRATION DATE: 2024-OCT-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R (K140826) LOT 188931: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JAN-2019. EXPIRATION DATE: 2024-JAN-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THE LOTS; 1811486, 1908699, 188931 REPORTED IN THE INITIAL MDR ARE NOT THE ONE REVISED IN THE SURGERY OF (B)(6) 2022. IN THEIR PLACE: BATCH REVIEW PERFORMED ON 22 FEBRUARY 2022. GMK-REVISION 02.07.2402R FEMUR REVISION PS SIZE 2 R (K102437) LOT 189488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2019. EXPIRATION DATE: 2024-FE-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721) LOT 1903716: 11 ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-SEP-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.2202R FEMUR PS CEMENTED SIZE 2 R (K090988) LOT 178082: 20 ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2018. EXPIRATION DATE: 2023-FEB-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.0210APPS FULL-PE PS TIBIAL COMPONENT SIZE 2/10 (K131310) LOT 188094: 15 ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2018. EXPIRATION DATE: 2023-NOV-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE SURGEON DECIDED TO RESURFACE THE PATIENT'S PATELLA. THE REASON FOR THIS ADDITIONAL PROCEDURE IS UNKNOWN. THE AGENT WAS NOT NOTIFIED OF THIS PROCEDURE UNTIL PRESENT AND A COMPLAINT WAS NOT FILED. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. IN 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A SPACER. THE AGENT WAS NOT AWARE OF THIS PROCEDURE AND MEDACTA IMPLANTS WERE NOT NEEDED ON THIS OCCASION DUE TO THE IMPLANTATION OF THE SPACER. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED THE SPACER AND IMPLANTED A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    ON (B)(6) 2020 PATIENT WAS REVISED FROM COMPETITOR TO MEDACTA IMPLANT; REVISION OF FEMUR AND POLY WITH ANTIBIOTIC CEMENT SPACER. ON (B)(6) 2020 SPACER WAS REMOVED AND PERMANENT HARDWARE IMPLANTED (MEDACTA). ON (B)(6) 2020 PATIENT'S NATURAL PATELLA RESURFACED, NO IMPLANTS REVISED. ON (B)(6) 2020 THE PATIENT WAS REVISED DUE TO INFECTION, ONLY LINER REVISED, ON (B)(6) 2020 PATIENT HAS INFECTION; HARDWARE REMOVED AND INSERT, FEMORAL, AND TIBIAL COMPONENT IMPLANTED WITH ANTIBIOTIC CEMENT TO ACT AS A SPACER. ON (B)(6) 2021 THE SPACER WAS REMOVED AND A NEW SPACER HAS BEEN IMPLANTED (FEMORAL COMPONENT AND FULL PE TIBIAL COMPONENT). PRESENTLY, ON (B)(6) 2022 THE SPACER WAS REMOVED AND HINGE SYSTEM HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110825 GMK-REVISION 02.07.0220SCF FIXED TIBIAL INSERT SC SIZE 2/20MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.07.0220SCF 177655 07630030816932

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention