BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L

    MDR report key: 11594050 · Received March 31, 2021

    Report

    Report Number
    3005180920-2021-00252
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862564
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    XRAYS ANALYSIS PERFORMED ON (B)(6) 2021. ALSO, EVENT DESCRIPTION HAS BEEN UPDATED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER INSERT REVISION IN TKA 5 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 · 0

    REVISION SURGERY HAS BEEN PERFORMED DUE TO KNEE INSTABILITY AFTER 5 MONTHS AND 18 DAYS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE LINER FROM 11MM TO 17MM.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16.03.2021: LOT 2000393: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO KNEE INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494837 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0311FL 2000393 07630030862564

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention