BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 2 R

    MDR report key: 13470615 · Received February 7, 2022

    Report

    Report Number
    3005180920-2022-00072
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 11, 2022
    Report Date
    February 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825422
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022 LOT 1810684: 19 ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-HINGE 02.07.FCL16105 EXTENSION STEM - FLUTED Ø 16 L 105 (K120790) LOT. 187635 BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022 LOT 187635: 20 ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2018. EXPIRATION DATE: 2023-11-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-HINGE 02.07.CM25 CENTRED 3DMETAL TIBIAL CONE M H25 (K170149) LOT. 172468 BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022 LOT 172468: 50 ITEMS MANUFACTURED AND RELEASED ON 23-JAN-2018. EXPIRATION DATE: 2023-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-HINGE 02.05.02DW FEMORAL WEDGE DISTAL # 2/8MM (K102437) LOT. 1811779 BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022 LOT 1811779: 27 ITEMS MANUFACTURED AND RELEASED ON 29-APR-2019. EXPIRATION DATE: 2024-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-HINGE 02.05.02DW FEMORAL WEDGE DISTAL # 2/8MM (K102437) LOT. 183229 BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022 LOT 183229: 27 ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2018. EXPIRATION DATE: 2023-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-HINGE 02.09.0212H FIXED TIBIAL INSERT # 2/12MM (K130299) LOT. 1904689 BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022 LOT 1904689: 10 ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2019. EXPIRATION DATE: 2024-06-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-HINGE 02.07.0036RP PATELLA RESURFACING # 4 (K113571) LOT. 2000634 BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022 LOT 2000634: 330 ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 311 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-HINGE 02.07.FCL14105 EXTENSION STEM - FLUTED Ø 14 L 105 (K120790) LOT. 1905621 BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022 LOT 1905621: 15 ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2019. EXPIRATION DATE: 2024-11-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD 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. 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. 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. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE FEMUR, STEM EXTENSION, AUGMENTS, POLY, AND PATELLA, PERFORMED A WASHOUT, AND THEN REIMPLANTED THE PATIENT WITH NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504852 GMK-HINGE FEMORAL COMPONENT SIZE 2 R CONSTRAINED CEMENTED FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 02.09.2602R 1810684 07630030825422

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention