BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R

    MDR report key: 11398441 · Received March 2, 2021

    Report

    Report Number
    3005180920-2021-00152
    Event Type
    Injury
    Date Received
    March 2, 2021
    Date of Event
    February 1, 2021
    Report Date
    March 2, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862540
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 FEBRUARY 2021: LOT 1900393: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2019. EXPIRATION DATE: 2024-04-14. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: ONE YEAR AFTER TKA THE PATIENT LAMENTS KNEE INSTABILITY. THIS IS ASSESSED TO BE DUE TO LIGAMENT LAXITY, INTERVENED OVER TIME. THE CAUSE OF THIS ADVERSE EVENT IS DISEASE PROGRESSION AND NOT A DEFECT OF THE IMPLANTED DEVICE. A THICKER INSERT SOLVED THE PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY THAT OCCURRED OVER TIME. THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 11MM S2 WITH A SPHERE INSERT FLEX RIGHT 13MM S2 1 YEAR AND 2 MONTHS AFTER PRIMARY, TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296248 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0211FR 1900393 07630030862540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention