BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R

    MDR report key: 19814525 · Received July 24, 2024

    Report

    Report Number
    3005180920-2024-00569
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862663
    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 19 JULY 2024: LOT 162639: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JULY-2016. EXPIRATION DATE: 2021-07-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303154 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 162639 07630030862663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention