BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 3 R

    MDR report key: 15093711 · Received July 25, 2022

    Report

    Report Number
    3005180920-2022-00571
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 5, 2022
    Report Date
    July 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825446
    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) 2022, LOT 189374: LOT 189374: 20 ITEMS MANUFACTURED AND RELEASED ON 25-APR-2019. EXPIRATION DATE: 2024-FEB-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTED COMPONENTS: BATCH REVIEW PERFORMED ON 11 JULY 2022 GMK-HINGE 02.09.0220UCH UC FIXED TIBIAL INSERT SIZE 2/20MM (K172347) LOT. 183630: LOT 183630: 11 ITEMS MANUFACTURED AND RELEASED ON 21-AUG-2018. EXPIRATION DATE: 2023-JUL.24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 3 SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 11 JULY 2022 GMK-HINGE 02.09.4002R FIXED TIBIAL TRAY SIZE 2 R (K130299) LOT. 189378: LOT 189378: 24 ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2018. EXPIRATION DATE: 2023-DEC-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND FUSED THE PATIENT'S KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96964 GMK-HINGE FEMORAL COMPONENT SIZE 3 R KNEE FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 02.09.2603R 189374 07630030825446

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention