BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 20405450 · Received October 9, 2024

    Report

    Report Number
    3005180920-2024-00828
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815775
    PMA / PMN Number
    K113571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 OCTOBER 2024. GMK-REVISION 02.07.0036RP PATELLA RESURFACING SIZE 4 LOT 2100666: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2021. EXPIRATION DATE: 2026-04-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 07 OCTOBER 2024. GMK-REVISION 02.07.0420SCF FIXED TIBIAL INSERT SC SIZE 4/20MM (K103170) LOT 2111951: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2022. EXPIRATION DATE: 2026-12-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 07 OCTOBER 2024. GMK-REVISION 02.07.0684R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R (K123721) LOT 2106366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2021. EXPIRATION DATE: 2026-08-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 07 OCTOBER 2024 GMK-REVISION 02.07.2404R FEMUR REVISION PS SIZE 4 R (K102437) LOT 2215537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. EXPIRATION DATE: 2027-10-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729241 GMK PRIMARY TOTAL KNEE SYSTEM KNEE PATELLA RESURFACING JWH MEDACTA INTERNATIONAL SA 02.07.0036RP 2215537 07630030815775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention