BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/26MM

    MDR report key: 9309055 · Received November 12, 2019

    Report

    Report Number
    3005180920-2019-00949
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    October 10, 2019
    Report Date
    November 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816987
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 OCTOBER 2019. LOT 183188: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2018. EXPIRATION DATE: 2023-06-06. 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

    THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH ALL COMPETITOR PRODUCTS. THE DATE OF THE PRIMARY SURGERY IS UNKNOWN. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED ALL PRIMARY IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2019, THE PATIENT CAME IN TO HAVE PERMANENT HARDWARE IMPLANTED. THE SURGEON IMPLANTED THE PATIENT WITH ALL MEDACTA REVISION IMPLANTS. PRESENTLY, ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY-INSERT, 2 WEEKS AFTER PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104087 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/26MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 183188 07630030816987

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention