BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 20545257 · Received October 28, 2024

    Report

    Report Number
    3005180920-2024-00894
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816680
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 OCTOBER 2024: LOT 2245222: 30 ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2023. EXPIRATION DATE: 2028-FEB-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 10 OCTOBER 2024: GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721) LOT 2313892: 48 ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2023. EXPIRATION DATE: 2028-OCT-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.2402R FEMUR REVISION PS SIZE 2 R LOT. 181228A (K102437) LOT 181228A: 3 ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2023. EXPIRATION DATE: 2028-SEP-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019382 GMK PRIMARY TOTAL KNEE SYSTEM GMK-REVISION TIBIAL INSERT PS FIXED SIZE 2/14MM JWH MEDACTA INTERNATIONAL SA 02.07.0214PSF 2245222 07630030816680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention