BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22518826 · Received July 16, 2025

    Report

    Report Number
    3005180920-2025-00687
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815737
    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 8 JULY 2025 LOT 2211064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25/07/2022. EXPIRATION DATE: 07/07/2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES REVISED BATCH REVIEWS PERFORMED ON 8 JULY 2025 GMK-PRIMARY 02.07.0210SF TIBIAL INSERT STD FIX S.2 / 10 MM (K090988) LOT 2302472: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19/05/2023. EXPIRATION DATE: 06/05/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.1202R TIBIAL TRAY FIX CEMENTED S.2R (K090988) LOT 2403142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13/05/2024. EXPIRATION DATE: 26/04/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.2003R FEMORAL COMPONENT CEMENTED STD SIZE 3 / RIGHT (K090988) LOT 2310633: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18/07/2023. EXPIRATION DATE: 29/06/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATELLA, POLY, TIBIAL TRAY, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152216 GMK PRIMARY TOTAL KNEE SYSTEM GMK-PRIMARY PATELLA RESURFACING S.1 (NEW GENERATION) JWH MEDACTA INTERNATIONAL SA 02.07.0033RP 2211064 07630030815737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention