BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 2 L

    MDR report key: 12009447 · Received June 16, 2021

    Report

    Report Number
    3005180920-2021-00486
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825415
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN HINGED TOTAL KNEE ARTHROPLASTY, 4 MONTHS AFTER IMPLANTATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. PRELIMINARY INVESTIGATION PERFORMED BY R&D MANAGER: REVISION SURGERY OF A GMK HINGE IMPLANT AFTER 4 MONTHS FROM PRIMARY IMPLANTATION DUE TO INFECTION. PICTURES OF THE EXPLANTED COMPONENTS HAVE BEEN SENT FOR INVESTIGATION. NO ANOMALIES CAN BE NOTED ON EXPLANTED COMPONENTS. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. THERE IS NO REASON TO SUSPECT THAT THE EVENT IS RELATED TO THE DEVICE. BATCH REVIEW PERFORMED ON 28 MAY 2021: LOT 189366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2019. EXPIRATION DATE: 2024-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 28 MAY 2021: GMK-HINGE 02.09.0314H FIXED TIBIAL INSERT SIZE 3/14MM (K130299) LOT 1810690: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2019. EXPIRATION DATE: 2024-04-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE 02.09.4003L FIXED TIBIAL TRAY SIZE 3 L (K130299) LOT 1906383: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE 02.07.204FDW FEMORAL WEDGE DISTAL SIZE 2/4MM (K102437) LOT 1908414: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE 02.07.FCL13065 EXTENSION STEM - FLUTED Ø 13 L 65 (K120790) LOT 1902929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JULY-2019. EXPIRATION DATE: 2024-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE 02.07.0005 OFFSET CONNECTOR 5 MM (K102437) LOT 2000828: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUNE-2020. EXPIRATION DATE: 2025-05-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE 02.07.FCL18065 EXTENSION STEM - FLUTED Ø 18 L 65 (K120790) LOT 1900655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUNE-2019. EXPIRATION DATE: 2024-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE 02.07.204FDW FEMORAL WEDGE DISTAL SIZE 2/4MM (K102437) LOT 1904844: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2019. EXPIRATION DATE: 2024-09-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    4 MONTHS AFTER MEDACTA DEVICES IMPLANTATION REVISION SURGERY FOR INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905971 GMK-HINGE FEMORAL COMPONENT SIZE 2 L CEMENTED FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 02.09.2602L 189366 07630030825415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention