BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 24738815 · Received March 31, 2026

    Report

    Report Number
    3005180920-2026-00291
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815775
    PMA / PMN Number
    K113571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MARCH 2026. GMK-SPHERE 02.07.0036RP RESURFACING PATELLA SIZE 4 (K11357) LOT 2012794: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MARCH-2021. EXPIRATION DATE: 2026-02-24. 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. GMK-SPHERE 02.07.1205R GMK TIBIAL TRAY CEMENTED RIGHT S5 (K090988) LOT 2203635: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUNE-2022. EXPIRATION DATE: 2027-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0026R SPHERE FEMUR CEMENTED RIGHT S6 + (K140826) LOT 1907946: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2019. EXPIRATION DATE: 2024-11-03. 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. GMK-SPHERE 02.12.0512FR GMK-SPHERE TIBIAL INSERT - FLEX S5R - 12 MM (K121416) LOT 2011405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JAN-2021. EXPIRATION DATE: 2025-12-13. 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. 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

    AT ABOUT 3 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION WITH CUTIBACTERIUM ACNES AND INSTABILITY. THE SURGEON PERFORMED A WASHOUT, AND REVISED ALL COMPONENTS FROM GMK-SPHERE TO GMK-REVISION FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802913 GMK PRIMARY TOTAL KNEE SYSTEM RESURFACING PATELLA SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.07.0036RP 2012794 07630030815775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention