BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 25185346 · Received May 15, 2026

    Report

    Report Number
    3005180920-2026-00453
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 15, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818332
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 MAY 2026 GMK-REVISION 02.07.0512SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 12 MM (K103170) LOT 2210522: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2022. EXPIRATION DATE: 2027-MAY-19. 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 02.07.4405R TINBN COATED FEMUR REVISION PS SIZE 5 R (K210010) LOT 2303983: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2023. EXPIRATION DATE: 2028-OCT-10. 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: THE SURGEON REVISED THE DEVICES TO RESTORE JOINT MOBILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AT 10 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN PRESENTING PAIN AND SEVERE FLEXION CONTRACTURE AND THE CAUSE IS UNKNOWN. THERE WERE NO REPORTS OF TRAUMA. THE SURGEON REVISED THE SEMICONSTRAINED 12MM S5 INSERT TO A SEMICONSTRAINED 10MM S5 INSERT, PERFORMEDADDITIONAL DISTAL RESECTION TO GAIN FULL EXTENSIONAND REVISED THE PS SIZE 5 R FEMUR WITH THE SAME SIZE FEMUR ALONG WITH AUGMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488808 GMK REVISION TOTAL KNEE SYSTEM FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 12 MM JWH MEDACTA INTERNATIONAL SA 02.07.0512SCF 2210522 07630030818332

    Patients

    Seq Age Sex Outcome Treatment
    1