BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE3 L

    MDR report key: 13042794 · Received December 20, 2021

    Report

    Report Number
    3005180920-2021-00991
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 20, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825439
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 NOVEMBER 2021. LOT 2010962: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2021. EXPIRATION DATE: 2026-FEB-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDTIONAL COMPONENTS INVOLVED: GMK-HINGE 02.09.0314H FIXED TIBIAL INSERT SIZE 3/14MM (K130299) LOT. 178882 LOT 178882: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2018. EXPIRATION DATE: 2023-APR-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE 02.09.4003L FIXED TIBIAL TRAY SIZE 3 L (K130299) LOT. 172031 LOT 172031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2017. EXPIRATION DATE: 2022-JUN-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    ABOUT 2 MONTHS AFTER THE PREVIOUS REVISION SURGERY(PREVIOUSLY ALL IMPLANTS WERE REVISED DUE TO THE TIBIA TENDON HAD COME OFF), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941977 GMK-HINGE FEMORAL COMPONENT SIZE3 L KNEE REVISION FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 02.09.2603L 2010962 07630030825439

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention