BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21932364 · Received April 30, 2025

    Report

    Report Number
    3005180920-2025-00369
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    April 3, 2025
    Report Date
    May 28, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15-APR-2025: LOT 2349049: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2024. EXPIRATION DATE: 25-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. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 15-APR-2025: GMK-SPHERIKA 02.12.0210CRR TIBIAL INSERT FIXED SPHERE CR SIZE 2/10 MM R (K181635) LOT 2342648: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2023. EXPIRATION DATE: 05-NOV-2028. 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.KA03R FEMORAL COMPONENT SPHERIKA CEMENTED S3R (K211004) LOT 2315331: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2023. EXPIRATION DATE: 20-AUG-2028. 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. 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.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION: 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. FOLLOWING A CALL WITH THE SURGEON, HE TOLD US 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.

    Description of Event or Problem · 0

    AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS. REHABILITATION HAS BEEN PERFORMED IN ORDER TO RESTORE THE JOINT MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674708 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 2 JWH MEDACTA INTERNATIONAL SA 02.07.1202R 2349049 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention