BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/26MM

    MDR report key: 8361565 · Received February 22, 2019

    Report

    Report Number
    3005180920-2019-00088
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 22, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818141
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 FEBRUARY 2019. LOT 183193: ITEMS MANUFACTURED AND RELEASED ON 28 JUNE 2018. EXPIRATION DATE: 06-18-2023 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    FIRST REVISION SURGERY PERFORMED DUE TO SUBLUXED TIBIA, AT THAT TIME A POLY SWAP WAS PERFORMED . PRESENTLY, 1 MONTH AFTER PRIMARY SURGERY, THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SUBLUXED TIBIA THE CAUSE OF THE SUBLUXATION IS UNKNOWN. A REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. SURGEON WILL CONTINUE TO MONITOR THE PATIENT, MAY HAVE TO USE A HINGE PROSTHESIS IF THE PATIENT'S KNEE DOES NOT TIGHTEN UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156955 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/26MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 183193 07630030818141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention