BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21812466 · Received April 10, 2025

    Report

    Report Number
    3005180920-2025-00258
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 17 MARCH 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2022. EXPIRATION DATE: 2027-03-21. 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. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS MANAGER: LESS THAN 3 YEARS AFTER PRIMARY CEMENTED TKA IN AN APPARENTLY SEVERE VALGUS KNEE, THE IMPLANTS ARE MOBILIZED AND AT REVISION SURGERY THE INSERT IS FOUND WORN WITH SIGN OF METAL-ON-METAL RUBBING. IN THE ONE PICTURE SUPPLIED, OF VERY LOW QUALITY, THE TIBIA APPEARS TO BE DETACHED FROM THE BONE, AND THE JOINT LINE SEEMS TO BE STRONGLY INCLINED - BUT WITH A SHORT LENGTH XRAY, NO PREOP IMAGES, NO CONTRALATERAL, THE RELEVANCE OF THIS OBSERVATION CANNOT BE GUARANTEED. IT IS POSSIBLE THAT THE EARLY LOOSENING AND THE BAD ARTICULATION ARE RELATED TO A WRONG ORIENTATION, BUT MORE INFORMATION IS NEEDED TO ASSESS THIS POINT. ADDITIONAL IMPLANTS ALSO REVISED: GMK-SPHERE 02.12.0410CRL TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L (K181635) LOT. 2112397 BATCH REVIEW PERFORMED ON 17 MARCH 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-10-07. 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 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE (K121416) 5 L LOT 2116063 BATCH REVIEW PERFORMED ON 17 MARCH 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2022. EXPIRATION DATE: 2027-01-11. 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.

    Description of Event or Problem · 0

    AT 2 YEARS 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE IMPLANTS ARE MOBILIZED AND UPON REVISING, THE PATIENT SHOWED SIGNS OF METALLOSIS AND A WORN POLY. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS. FROM THE X-RAYS ANALYSIS, THE TIBIA APPEARS TO BE DETACHED FROM THE BONE, AND THE JOINT LINE SEEMS TO BE STRONGLY INCLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454824 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIXED CEMENTED SIZE 4 L JWH MEDACTA INTERNATIONAL SA 02.07.1204L 2116000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention