BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK IMPLANTS

    MDR report key: 23583097 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01117
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 3 NOVEMBER 2025: GMK-SPHERE 02.07.1202R TIBIAL TRAY FIX CEMENTED S.2R (K090988) LOT 1901597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-JUL-03. 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. GMK-SPHERE 02.12.0023R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3+R (K140826) LOT 1901886: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-JUN-04. 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. ROOT CAUSE: 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

    THE PATIENT HAD PAIN DUE TO A LOOSE TIBIA AND FEMUR IMPLANTS. AT ABOUT 6 YEARS POST PRIMARY THE SURGEON REVISED THE TIBIA, INSERT, AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. LACK OF ADHERENCE TO CEMENT FOUND. NON MEDACTA CEMENT WAS USED DURING PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236431 GMK IMPLANTS TIBIAL TRAY FIX CEMENTED S.2R JWH MEDACTA INTERNATIONAL SA 02.07.1202R 1901597 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention