BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 21618032 · Received March 17, 2025

    Report

    Report Number
    3005180920-2025-00234
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    January 24, 2025
    Report Date
    May 20, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345716125
    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 03-03-2025: LOT 2401766: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-07-2024. EXPIRATION DATE: 2029-07-03. 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 IMPLANTS INVOLVED; BATCH REVIEW PERFORMED ON 03-03-2025: GMK-SPHERIKA 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT 2416662: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-09-2024. EXPIRATION DATE: 2029-09-12. 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. E0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS (K202022) LOT 2414989: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-07-2024. EXPIRATION DATE: 2029-07-10. 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. THE DEVELOPMENT OF STIFFNESS OF THE JOINT IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, SURGEON DECIDED TO TREAT THE PATIENT WITH KNEE MANIPULATION. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    CLINCAL EVALUATION PERFORMED BY CLINCAL AFFAIRS DEPARTMENT: FEW MONTHS AFTER PRIMARY TKA, STIFFNESS IS FELT BY THE PATIENT AND MOBILIZATION UNDER ANESTHESIA IS CARRIED OUT. ACCORDING TO THE SURGEON, THIS TREATMENT SOLVED THE PROBLEM. THE SURGEON HIMSELF SAID THAT THIS IS A TYPE OF SITUATION THAT OCCASIONALLY PRESENTS ITSELF AFTER TKA, AND HE THINKS THERE IS NO RELATION WHATSOEVER WITH THE DEVICE IMPLANTED. INFORMATION REPORTED IN THIS FOLLOW UP: - CLINICAL EVALUATION IN THE SECTION H11.

    Description of Event or Problem · 0

    ADVERSE EVENT DURING CLINICAL STUDY. AT ABOUT 1 MONTH AND A HALF FROM PRIMARY SURGERY, THE SURGEON TREATED THE PATIENT FOR RIGIDITY AND STIFFNESS OF THE KNEE UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4514 GMK TOTAL KNEE SYSTEM FEMORAL COMPONENT SPHERIKA CEMENTED S5R JWH MEDACTA INTERNATIONAL SA 02.12.KA05R 2401766 07630345716125

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other