BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE 02.09.0523H FIXED TIBIAL INSERT SIZE 5/23MM

    MDR report key: 17886291 · Received October 6, 2023

    Report

    Report Number
    3005180920-2023-00783
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825309
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 189424: 20 ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: GMK-HINGE 02.09.2606L FEMORAL COMPONENT SIZE 6 L (K130299) LOT. 1908921: 14 ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2020. EXPIRATION DATE: 2025-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-HINGE 02.09.4005L FIXED TIBIAL TRAY SIZE 5 L (K130299) LOT 1907623: 7 ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2020. EXPIRATION DATE: 2025-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE PATIENT HAD A HYPER-EXTENDED MEDACTA HINGE KNEE AND THE CAUSE IS UNKNOWN. NO REVISION SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202350 GMK-HINGE 02.09.0523H FIXED TIBIAL INSERT SIZE 5/23MM KNEE FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 189424 07630030825309

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention