BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/10MM

    MDR report key: 16322189 · Received February 8, 2023

    Report

    Report Number
    3005180920-2023-00047
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    January 14, 2023
    Report Date
    February 8, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817076
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-JAN-2023: LOT 183189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2023-07-17. 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

    THE PATIENT HAD A PRIMARY SURGERY WITH COMPETITOR COMPONENTS AND WAS REVISED TO MEDACTA REVISION COMPONENTS ON THE (B)(6) 2019. PRESENTLY ON THE (B)(6) 2023, 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
    2315678 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/10MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0310SCF 183189 07630030817076

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention