BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 12 MM

    MDR report key: 6057186 · Received October 26, 2016

    Report

    Report Number
    3005180920-2016-00539
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07 OCTOBER 2016 THE PATIENT MATCHED DEPARTMENT PERFORMED A PATIENT MATCH PLANNING REVIEW, REPORTING AS FOLLOWS: OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. ON 21 OCTOBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION OF THE CASE AND COMMENTED AS FOLLOWS: INSERT REVISION IN TKA 8 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 26 OCTOBER 2016. LOT 141644: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 MAY 2014. EXPIRATION DATE: 2019-03-31. 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 CAME IN COMPLAINING OF INSTABILITY. THE SURGEON REVISED THE INSERT FROM A 12MM TO A 14MM. THE PATIENT DEVELOPED LAXITY OVER TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710211 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 12 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141644

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention