BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 22894250 · Received August 26, 2025

    Report

    Report Number
    3005180920-2025-00833
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345716224
    PMA / PMN Number
    K211004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 AUG 2025. GMK-SPHERIKA 02.12.KA13R GMK SPHERIKA FEMORAL COMPONENT S3+R CEMENTED (K211004) LOT. 2408292: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUL-2024. EXPIRATION DATE: 2029-06-19. 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. ADDITIONAL DEVICES ALSO REVISED: GMK-SPHERIKA 02.12.0212FR GMK-SPHERE TIBIAL INSERT - FLEX S2R - 12 MM (K121416) LOT. 2338835: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2023. EXPIRATION DATE: 2028-09-23. 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-SPHERIKA 02.12.3D02R GMK 3DMETAL TIBIAL TRAY SIZE 2R (K221850) LOT. 2308265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2023. EXPIRATION DATE: 2028-09-14. 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.

    Additional Manufacturer Narrative · 0

    INITIAL EMDR WAS SUBMITTED ON THE SAME DAY WHEN THE INVOLVED DEVICES WERE RECEIVED BY THE MANUFACTURER AND THE ANALYSIS WAS YET TO BE PERFORMED. VISUAL INSPECTION PERFORMED BY R&D DEPARTMENT: THE EXPLANTED 3DM TIBIAL BASEPLATE AND CEMENTLESS FEMORAL COMPONENT WERE VISUALLY INSPECTED UPON RETURN FOR INVESTIGATION. DESPITE THE PRESENCE OF INFECTION, BOTH COMPONENTS APPEARED TO HABE BEEN WELL INTEGRATED, WITH RESIDUAL BONE OBSERVED WITHIN THE POROUS STRUCTURE DESIGNED TO ENABLE BONE INGROWTH. THE REVISION SURGERY WAS NECESSITATED BY INFECTION. BASED ON THE VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THE EVENT WAS RELATED TO A DEFECTIVE DEVICE. UPDATED FIELDS D9. H11.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY, WITH SUBSEQUENT POSTOPERATIVE HEALING DIFFICULTIES. AT THE MOST RECENT FOLLOW-UP, THE PATIENT REPORTED WORSENING PAIN ASSOCIATED WITH INTERNAL INSTABILITY, ALONG WITH MARKED PAIN IN THE TIBIAL METAPHYSIS AND THE FEMOROPATELLAR JOINT. AT 11 MONTHS FROM THE PRIMARY, REVISION SURGERY WAS PERFORMED IMPLANTING A SEMI-CONSTRAINED KNEE PROSTHESIS. INTRAOPERATIVE SAMPLES CONFIRMED THE PRESENCE OF CHRONIC PERIPROSTHETIC INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506762 GMK TOTAL KNEE SYSTEM GMK SPHERIKA FEMORAL COMPONENT S3+R CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.KA13R 2408292 07630345716224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention