BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE AND REVISION TINBN COATED

    MDR report key: 23837292 · Received December 18, 2025

    Report

    Report Number
    3005180920-2025-01271
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040721820
    PMA / PMN Number
    K210010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 9 DECEMBER 2025. GMK-HINGE 02.09.2702R GMK-HINGE FEMORAL COMPONENT #2 R - TINBN COATED (K210010) LOT 2112357: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03/03/2022. EXPIRATION DATE: 14 FEBRUARY 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. 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. STYLE DEFINITIONS. TABLE.MSONORMALTABLE. MSO-STYLE-NAME:"TABELLA NORMALE"; MSO-TSTYLE-ROWBAND-SIZE:0; MSO-TSTYLE-COLBAND-SIZE:0; MSO-STYLE-NOSHOW:YES; MSO-STYLE-PRIORITY:99; MSO-STYLE-PARENT:""; MSO-PADDING-ALT:0CM 5.4PT 0CM 5.4PT; MSO-PARA-MARGIN-TOP:0CM; MSO-PARA-MARGIN-RIGHT:0CM; MSO-PARA-MARGIN-BOTTOM:8.0PT; MSO-PARA-MARGIN-LEFT:0CM; LINE-HEIGHT:107%; MSO-PAGINATION:WIDOW-ORPHAN; FONT-SIZE:11.0PT; FONT-FAMILY:"CALIBRI",SANS-SERIF; MSO-ASCII-FONT-FAMILY:CALIBRI; MSO-ASCII-THEME-FONT:MINOR-LATIN; MSO-HANSI-FONT-FAMILY:CALIBRI; MSO-HANSI-THEME-FONT:MINOR-LATIN; MSO-BIDI-FONT-FAMILY:"TIMES NEW ROMAN"; MSO-BIDI-THEME-FONT:MINOR-BIDI; MSO-FONT-KERNING:1.0PT; MSO-LIGATURES:STANDARD CONTEXTUAL; MSO-FAREAST-LANGUAGE:EN-US. BATCH REVIEW PERFORMED ON 9 DECEMBER 2025. GMK-HINGE 02.09.2702R GMK-HINGE FEMORAL COMPONENT SIZE2 R, TINBN COATED (K210010) LOT 2112357: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03/03/2022. EXPIRATION DATE: 14 FEBRUARY 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. 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 PRIMARY RIGHT KNEE SURGERY UTILIZING COMPETITOR PRODUCTS. ON (B)(6) 2024. A REVISION WAS PERFORMED USING MEDATA HINGE IMPLANTS, AND THE SURGEON RETAINED THE COMPETITOR PATELLA FROM THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A BROKEN DISTAL FEMUR BONE AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE POLY, TIBIA AND FEMUR, REPLACING THEM WITH COMPETITOR IMPLANTS. THE PATIENT HAD A COMPETITOR PATELLA, WHICH FELL OUT UPON MAKING THE INCISION. THE SURGEON REVISED THE COMPETITOR PATELLA WITH A MEDACTA PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618612 GMK HINGE AND REVISION TINBN COATED GMK-HINGE FEMORAL COMPONENT SIZE2 R - TINBN COATED JWH MEDACTA INTERNATIONAL SA 02.09.2702R 2112357 07630040721820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention