BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 23063083 · Received September 16, 2025

    Report

    Report Number
    3005180920-2025-00879
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816581
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 01 SEPTEMBER 2025: GMK-REVISION 02.07.0212PSF TIBIAL INSERT PS FIX S.2 / 12 MM (K090988) LOT: 2242132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2024. EXPIRATION DATE: 2027-12-26. 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 INVOLVED: GMK-REVISION 02.07.0682L REVISION TIBIAL TRAY SIZE 2 LEFT - FINISHING (K123721) LOT: 2316790: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2023. EXPIRATION DATE: 2028-12-09. 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-REVISION 02.07.2403L FEMUR REVISION PS CEMENTED S.3L (K102437) LOT: 2118569: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2022. EXPIRATION DATE: 2027-04-20. 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

    REVISION DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286595 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL INSERT PS FIX S.2 / 12 MM JWH MEDACTA INTERNATIONAL SA 02.07.0212PSF 2242132 07630030816581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention