BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM

    MDR report key: 12859348 · Received November 23, 2021

    Report

    Report Number
    3005180920-2021-00945
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 5, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817564
    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 12 NOVEMBER 2021: LOT 1904799: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-LUG-2019. EXPIRATION DATE: 2024-08-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 1 MONTH AFTER THE LAST SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A QUAD TENDON RUPTURE AND THE CAUSE OF THE QUAD TENDON RUPTURE IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PREVIOUS REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO A FALL AND PATELLA BONE RUPTURE. THE SURGEON PERFORMED A PATELLECTOMY AND RETINACULUM REPAIR AND REVISED THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757964 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0326SCF 1904799 07630030817564

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention