BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21772690 · Received April 4, 2025

    Report

    Report Number
    3005180920-2025-00246
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-MAR-2025 LOT 2002933: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2020. EXPIRATION DATE: 05-MAY-2025. 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. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0410CRL TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L (K181635) LOT 2003196: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUL-2020. EXPIRATION DATE: 19-JUL-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANALYSIS PERFORMED BY R&D MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 4 YEARS AND 4 MONTHS FROM PRIMARY IMPLANTATION DUE TO ASEPTIC LOOSENING OF FEMORAL COMPONENT AND TIBIA BASEPLATE. THE INVESTIGATION IS BASED ON THE PICTURE OF THE EXPLANTED TIBIAL TRAY, IN WHICH NO RESIDUAL CEMENT CAN BE NOTED ON THE DISTAL SURFACE OF THE TIBIAL BASEPLATE. NO ANOMALIES CAN BE NOTED ON THE TIBIAL BASEPLATE IMPLANT. THE EVENT OF A POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT FOR BOTH TIBIAL AND FEMORAL COMPONENTS CAN BE RELATED TO MULTIPLE FACTORS, MOST LIKELY NOT IMPLANT RELATED (SUCH AS CEMENTATION PROCESS, TEMPERATURE, CEMENTATION TIMING, PRESENCE OF FLUIDS ON THE SURFACES OF CEMENT INTERFACE). FROM THE ANALYSIS, THERE IS NO EVIDENCE TO SUSPECT THAT THE EVENT IS RELATED TO FAULTY DEVICES. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON DECIDED TO REVISE THE PATIENT, AND DURING THE REVISION IT WAS OBSERVED THAT THE PRIMARY IMPLANTS WERE ALL LOOSE WITH LITTLE TO NO CEMENT ADHERENCE. THE SURGEON REVISED ALL IMPLANTS TO GMK-REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632425 GMK PRIMARY TOTAL KNEE SYSTEM GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L JWH MEDACTA INTERNATIONAL SA 02.07.1204L 2002933 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention