BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 24455600 · Received February 26, 2026

    Report

    Report Number
    3005180920-2026-00127
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817168
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 09 FEBRUARY 2026: GMK-PRIMARY 02.07.312PSF TIBIAL INSERT PS FIX S.3 / 12 MM (K090988) LOT 145633: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-NOV-2014. EXPIRATION DATE: 2019-OCT-30. 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 02.07.2203L FEMORAL COMPONENT CEMENTED PS SIZE 3 / LEFT (K090988) LOT 168673: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2017. EXPIRATION DATE: 2022-FEB-30. 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.F11030 PRIMARY EXTENSION STEM D 11MM L30MM (K133630) LOT 168578: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2017. EXPIRATION DATE: 2022-MAR-2022. 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. ROOT CAUSE: 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 HAD A KNEE REVISION DUE TO INFECTION. DURING THE SURGEON THE FEMUR WAS FOUND SEPTIC LOOSEN. ALL DEVICES REVISED SUCCESSFULLY AT ABOUT 7 YEARS AND 3 MONTHS POST PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520315 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL INSERT PS FIX S.3 / 12 MM JWH MEDACTA INTERNATIONAL SA 02.07.0312PSF 145633 07630030817168

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention