BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM

    MDR report key: 11300090 · Received February 9, 2021

    Report

    Report Number
    3005180920-2021-00104
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 13, 2021
    Report Date
    February 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816499
    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 09 FEBRUARY 2021: LOT 170555: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MARCH-2017. EXPIRATION DATE: 2022-02-15. 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 · 1

    REVISION SURGERY PERFORMED DUE TO QUAD TENDON RUPTURE AND THE CAUSE OF THE RUPTURE IS UNKNOWN. THE SURGEON REPAIRED THE QUAD TENDON AND REVISED THE LINER 11 MONTHS AFTER A FIRST REVISION SURGERY (WHICH WAS DUE TO KNEE STIFFNESS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198246 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0210SCF 170555 07630030816499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention