BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION TIBIAL INSERT PS FIXED SIZE 4/12MM

    MDR report key: 11640108 · Received April 9, 2021

    Report

    Report Number
    3005180920-2021-00277
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817748
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 MARCH 2021: LOT 173732: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2017. EXPIRATION DATE: 2022-07-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY SURGERY AND WAS IMPLANTED WITH COMPETITOR IMPLANTS. ON (B)(6) 2021, THE PATIENT HAD THE COMPETITOR IMPLANTS REVISED TO MEDACTA IMPLANTS FOR REASONS UNKNOWN. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON. THE CAUSE OF THE TORN PATELLA TENDON IS UNKNOWN. THE SURGEON REPAIRED THE PATELLA TENDON AND REVISED THE INSERT P.S. 12MM S4 WITH A INSERT SEMICONSTRAINED 12MM S4. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538945 GMK-REVISION TIBIAL INSERT PS FIXED SIZE 4/12MM TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0412PSF 173732 07630030817748

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention