BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 10 MM

    MDR report key: 12665545 · Received October 20, 2021

    Report

    Report Number
    3005180920-2021-00811
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    September 20, 2021
    Report Date
    October 20, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817083
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 24 SEPTEMBER 2021: LOT 133263: 60 ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2013. EXPIRATION DATE: 2018-SEP-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. CLINICAL EVALUATION: INSERT REVISION IN TKA 5 YEARS AND 9 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE PAIN INSTABILITY IS UNKNOWN. ABOUT 5 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT STD. 10MM S3 WITH AN INSERT U.C. 14MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563535 GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 10 MM TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0310SF 133263 07630030817083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention