BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL TRAY SIZE 3 R

    MDR report key: 8939188 · Received August 28, 2019

    Report

    Report Number
    3005180920-2019-00710
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825569
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 7 AUGUST 2019: LOT 185147: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 SEPTEMBER 2018. EXPIRATION DATE: 2023-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEWS PERFORMED ON 7 AUGUST 2019: GMK-HINGE 02.07.0005 OFFSET CONNECTOR 5 MM (K102437) LOT. 185144: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 SEPTEMBER 2018. EXPIRATION DATE: 2023-08-22. 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.FCL13105 EXTENSION STEM - FLUTED Ø 13 L 105 (K120790) LOT. 183202: LOT 183202: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5 "LULY" 2018. EXPIRATION DATE: 2023-06-25. 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 02.05.04DW FEMORAL WEDGE DISTAL SIZE 4/8MM (K102437) LOT. 178529: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4 JANUARY 2018. EXPIRATION DATE: 2022-12-10. 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 02.05.04DW FEMORAL WEDGE DISTAL SIZE 4/8MM (K102437) LOT. 156187: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1 FEBRUARY 2016. EXPIRATION DATE: 2021-01-19. 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 02.07.0003 OFFSET CONNECTOR 3 MM (K102437) LOT. 186603: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 9 OCTOBER 2018. EXPIRATION DATE: 2023-09-23. 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. GMK-HINGE 02.05.04PW FEMORAL WEDGE POSTERIOR SIZE 4/5MM (K102437) LOT. 179819: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3 APRIL 2018. EXPIRATION DATE: 2023-03-09. 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.FCL15105 EXTENSION STEM - FLUTED Ø 15 L 105 (K120790) LOT. 183205: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5 JULY 2018. EXPIRATION DATE: 2023-06-25. 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-SPHERE 02.09.0312H FIXED TIBIAL INSERT SIZE 3/12MM (K130299) LOT. 174544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-22. 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 02.09.2604R FEMORAL COMPONENT SIZE 4 R (K130299) LOT. 183240: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 AUGUST 2018. EXPIRATION DATE: 2023-07-18. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY AND COMPETITORS' PRODUCTS WERE IMPLANTED, THE DATE OF THE PRIMARY IS UNKNOWN. ON (B)(6) 2018 THE COMPETITOR DEVICES WERE REVISED AND MEDACTA KNEE SYSTEM IMPLANTED. THE REASON OF THIS REVISION WAS UNKNOWN. 5 MONTHS AFTER MEDACTA SYSTEM IMPLANTATION NEW REVISION SURGERY PERFORMED DUE TO AND INFECTION (THE PATHOGEN WAS UNKNOWN). THE SURGEON IMPLANTED AN ANTIBIOTIC SPACER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CURRENTLY, AFTER 3 MONTHS FROM IMPLANTATION OF THE ANTIBIOTIC SPACER, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733447 GMK-HINGE FIXED TIBIAL TRAY SIZE 3 R KNEE TIBIAL TRAY KRO MEDACTA INTERNATIONAL SA 185147 07630030825569

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention