BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18083885 · Received November 7, 2023

    Report

    Report Number
    3005180920-2023-00812
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 9, 2023
    Report Date
    November 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862557
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 OCTOBER 2023: LOT 1900395: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6-MAY-2019. EXPIRATION DATE: 2024-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 6 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 13 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349285 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1900395 07630030862557

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention