BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 12688357 · Received October 25, 2021

    Report

    Report Number
    3005180920-2021-00827
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 OCTOBER 2021: LOT 173771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-OCT-2017. EXPIRATION DATE: 2022-09-17. 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 4 YEARS 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

    AT 3 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REVISED THE LINER (FROM 10MM TO 14 MM) DUE TO INSTABILITY CAUSED BY LAXITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591060 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 173771 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention