BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL TRAY SIZE 4 R

    MDR report key: 10755289 · Received October 29, 2020

    Report

    Report Number
    3005180920-2020-00761
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    October 1, 2020
    Report Date
    January 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825583
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER DEVICES INVOLVED IN THE EVENT. BATCH REVIEW PERFORMED ON 08 OCTOBER 2020: GMK-HINGE 02.09.2604R FEMORAL COMPONENT SIZE 4 R LOT. 1904680 (K130299): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2020: LOT 1907619: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JAN-2020. EXPIRATION DATE: 2024-12-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: GMK-HINGE 02.09.2604R FEMORAL COMPONENT SIZE 4 R LOT. 1904680 (K130299). BATCH REVIEW PERFORMED ON 08 OCTOBER 2020: LOT 1904680: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, XX ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-HINGE 02.09.0420H FIXED TIBIAL INSERT SIZE 4/20MM LOT. 1900730 (K130299). BATCH REVIEW PERFORMED ON 08 OCTOBER 2020: LOT 1900730: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-HINGE 02.07.FCL16065 EXTENSION STEM - FLUTED Ø 16 L 65 LOT. 1902936 (K120790). BATCH REVIEW PERFORMED ON 08 OCTOBER 2020: LOT 1902936: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-HINGE 02.07.FCL13065 EXTENSION STEM - FLUTED Ø 13 L 65 LOT. 1905619 (K120790). BATCH REVIEW PERFORMED ON 08 OCTOBER 2020: LOT 1905619: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2019. EXPIRATION DATE: 2024-11-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK HINGE 02.07.0003 OFFSET CONNECTOR 3 MM LOT. 1909718 (K102437). BATCH REVIEW PERFORMED ON 08 OCTOBER 2020: LOT 1909718: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-HINGE 02.07.0034RP PATELLA RESURFACING SIZE 2 LOT. 1908302 (K090988). BATCH REVIEW PERFORMED ON 08 OCTOBER 2020: LOT 1908302: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2019. EXPIRATION DATE: 2024-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION: REVISION SURGERY AFTER 1 MONTH FROM IMPLANTATION DUE TO INFECTION OF A GMK HINGE IMPLANT. PICTURE OF THE EXPLANTED COMPONENTS DOESN'T REVEALED ANY ANOMALIES. CAUSE FOR INFECTION REMAINS UNKNOWN. THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE. CLINICAL EVALUATION: EARLY INFECTION IN HINGED TKA, FEW WEEKS AFTER PRIMARY OPERATION. 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.

    Description of Event or Problem · 1

    REVISION SURGERY FOLLOWING AN INFECTION PERFORMED ON THE (B)(6) 2020, 1 MONTH AFTER PRIMARY. ALL DEVICES EXPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221946 GMK-HINGE FIXED TIBIAL TRAY SIZE 4 R FIXED TIBIAL TRAY KRO MEDACTA INTERNATIONAL SA 02.09.4004R 1907619 07630030825583

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention