BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/20MM

    MDR report key: 12370172 · Received August 26, 2021

    Report

    Report Number
    3005180920-2021-00676
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    July 27, 2021
    Report Date
    August 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818097
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 AUGUST 2021: LOT 1906430: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEP-2019. EXPIRATION DATE: 2024-08-19. 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. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 01 AUGUST 2021: GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R LOT. 167068: LOT 167068: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2017. EXPIRATION DATE: 2021-12-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL13065 EXTENSION STEM - FLUTED Ø 13 L 65 LOT. 115703A: LOT 115703A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2017. EXPIRATION DATE: 2022-10-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0005 OFFSET CONNECTOR 5 MM LOT. 1909719: LOT 1909719: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2020. EXPIRATION DATE: 2025-02-04. 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-REVISION 02.07.1204R FIXED TIBIAL TRAY CEMENTED SIZE 4 R LOT. 111454: LOT 111454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2011. EXPIRATION DATE: 2016-04-30. 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 SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2012 AND HAD THE TOTAL KNEE IMPLANTED AROUND A NAIL. ON (B)(6) 2021, THE SURGEON REMOVED THE FEMORAL COMPONENT AND POLY TO REMOVE THE NAIL. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266511 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/20MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.07.0420SCF 1906430 07630030818097

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention