BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 12 MM

    MDR report key: 7237455 · Received February 2, 2018

    Report

    Report Number
    3005180920-2018-00787
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    September 17, 2018
    Report Date
    February 2, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826375
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON OCT 5, 2018: INSERT REVISION IN TKA 10 MONTHS AFTER PRIMARY FOR JOINT INSTABILITY. THE INSERT WAS EXCHANGED TO A THICKER ONE. THE DEVELOPMENTAL INSTABILITY IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, BECAUSE SOFT TISSUE MAY STRETCH AND PROVIDE INSUFFICIENT STABILITY. IT IS THEREFORE COMMON PRACTICE TO RESORT TO A THICKER INSERT AND RECREATE SOFT TISSUE TENSION. THIS IS NOT A PROBLEM DUE TO ANY IMPLANT DEFECT OR MALFUNCTION. BATCH REVIEW PERFORMED ON 16 OCTOBER 2018: LOT 170292: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 APRIL 2017. EXPIRATION DATE: 2022-04-06. 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.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018 WE WERE INFORMED THAT THE REVISION SURGERY HAS BEEN SUCCESSFULLY PERFORMED ON (B)(6) 2018.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO KNEE INSTABILITY AFTER ABOUT 1 YEAR FROM PRIMARY. THE SURGEON REVISED THE 12MM LINER TO A 14MM LINER.

    Description of Event or Problem · 1

    THE SURGEON REVISED THE PATIENT 8 MONTHS AFTER PRIMARY FOR A KNEE INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78697 GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 12 MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 170292 07630030826375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention