BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20530681 · Received October 25, 2024

    Report

    Report Number
    3005180920-2024-00890
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    September 27, 2024
    Report Date
    October 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826788
    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 21 OCTOBER 2024. LOT 2201082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2022. EXPIRATION DATE: 2027-04-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 90 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM TO 14MM) AND THE SURGERY WAS COMPLETELY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092914 GMK SPHERE TOTAL KNEE SYSTEM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0512FR 2201082 07630030826788

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention