BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM

    MDR report key: 19465901 · Received June 5, 2024

    Report

    Report Number
    3005180920-2024-00398
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817410
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 JUNE 2024: LOT 189534: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2019. EXPIRATION DATE: 2024-02-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 04 JUNE 2024: GMK-REVISION 02.07.0683R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 R (K123721) LOT 1901732: 9 ITEMS MANUFACTURED AND RELEASED ON 08-JULY-2019 EXPIRATION DATE: 2024-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R (K102437) LOT 2007462: 9 ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2020. EXPIRATION DATE: 2025-10-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY COMPETITOR KNEE SURGERY AND CAME IN DUE TO SIGNS OF AN INFECTION. ON (B)(6) 2021, THE SURGEON REVISED THE COMPETITOR COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN AND HAD THE ANTIBIOTIC SPACER REMOVED AND HAD GMK-REVISION COMPONENTS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802818 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 189534 07630030817410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention