BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

    MDR report key: 15750885 · Received November 8, 2022

    Report

    Report Number
    3005180920-2022-00834
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 15, 2022
    Report Date
    November 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816833
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-OCT-2022: LOT 183185: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2018. EXPIRATION DATE: 2023-06-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251631 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0217SCF 183185 07630030816833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention