BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20124868 · Received September 3, 2024

    Report

    Report Number
    3005180920-2024-00701
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    July 30, 2024
    Report Date
    September 3, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-AUG-2024. LOT 2116902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JAN-2022. EXPIRATION DATE: 2027-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY 2 YEARS AND 1 MONTH AFTER THE PRIMARY. THE SURGEON UPSIZED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834090 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2116902 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention