BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 25160337 · Received May 13, 2026

    Report

    Report Number
    3005180920-2026-00415
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819841
    PMA / PMN Number
    K090988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 APRIL 2026 GMK-SPHERE 02.07.1201L TIBIAL TRAY FIX CEMENTED S.1L (K090988) LOT 2345276: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2024. EXPIRATION DATE: 24-FEB-2029. 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-SPHERE 02.12.0110FL GMK-SPHERE TIBIAL INSERT - FLEX S1L - 10 MM (K121416) LOT 2404038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2024. EXPIRATION DATE: 10-MAR-2029. 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-SPHERE 02.12.0111FL GMK-SPHERE TIBIAL INSERT - FLEX S1L - 11 MM (K140826) LOT 2349252: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2024. EXPIRATION DATE: 06-FEB-2029. 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 EFFICIENCY 77.11.1110 TRIAL INSERT FLEX S1 - 10L LOT 2205467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2022. EXPIRATION DATE: 05-APR-2027. 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 BATCH REVIEW WAS PERFORMED ON THE TRAY SET, AS IT IS NOT POSSIBLE TO CONDUCT IT ON THE SPECIFIC COMPONENT INVOLVED IN THE COMPLAINT, I.E. THE TRIAL INSERT FLEX S1 - 10L (LOT MAT37802), FOR WHICH 300 UNITS WERE PURCHASED FROM ONOSTAMPI SRL. ROOT CAUSE: ALTHOUGH NO ROOT CAUSE CAN BE CONFIRMED, IT IS MOST LIKELY THAT THE PROLONGED SURGICAL TIME WAS RELATED TO DIFFICULTIES ENCOUNTERED DURING THE POSITIONING AND FIXATION OF THE INSERT ONTO THE TRAY, REQUIRING MULTIPLE ATTEMPTS BEFORE SUCCESSFUL ASSEMBLY. THE INVESTIGATION DOES NOT INDICATE A POTENTIAL MANUFACTURING-RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    THE SURGEON EXPERIENCED DIFFICULTY INSERTING THE EFFICIENCY 10 MM LEFT INSERT INTO A SIZE 1 LEFT CEMENTED TIBIAL BASEPLATE, REQUIRING MULTIPLE ATTEMPTS. THE PATIENT ACHIEVED FULL EXTENSION WITH A ROM OF 120°, WITH NO TIGHTNESS ISSUES. DIFFICULTY WAS ALSO ENCOUNTERED WHEN INSERTING THE DEFINITIVE 10 MM POLYETHYLENE INSERT, LEADING TO DAMAGE TO ITS POSTERIOR ASPECT AFTER REPEATED ATTEMPTS. AN 11 MM INSERT WAS THEN TRIED, ALSO WITH MULTIPLE ATTEMPTS, AND WAS ULTIMATELY FORCEFULLY IMPACTED USING A TIBIAL IMPACTOR. THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48194 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIX CEMENTED S.1L JWH MEDACTA INTERNATIONAL SA 02.07.1201L 2345276 07630030819841

    Patients

    Seq Age Sex Outcome Treatment
    1