BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    MDR report key: 17348647 · Received July 19, 2023

    Report

    Report Number
    3005180920-2023-00529
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    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 27 JUNE 2023. LOT 183059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2018. EXPIRATION DATE: 2023-JUL-15. 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

    THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2010. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE PATELLA AND TIBIA. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, INSERT, AND PATELLA AND ADDED AN EXTENSION STEM AND CONE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON OPENED THE PATIENT AND FOUND NO IMPLANTS TO BE LOOSE. HE REVISED THE POLY (WITH ONE OF THE SAME THICKNESS; NO INSTABILITY REPORTED) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37410 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0412FR 183059 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention