BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM

    MDR report key: 8252590 · Received January 16, 2019

    Report

    Report Number
    3005180920-2018-01093
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    December 18, 2018
    Report Date
    January 16, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817618
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 JANUARY 2019: LOT 143618: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS REVISED: GMK-PRIMARY 02.07.1204L TIBIAL TRAY FIXED CEMENTED # 4 L, (K090988) LOT 147036: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2015. EXPIRATION DATE: 2019-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.2014L FEMUR CEMENTED STD #4NARROW / LEFT, (K122232) LOT 147868: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2015. EXPIRATION DATE: 2019-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON "DEC 17", 2018 WE WERE INFORMED ABOUT A PATIENT WHO CAME IN DUE TO LAXITY. ON THE FOLLOWING DAY, THE SURGEON REVISED THE, POLY, TIBIAL TRAY AND FEMORAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44676 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 143618 07630030817618

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention