BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20459598 · Received October 16, 2024

    Report

    Report Number
    3005180920-2024-00832
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261280
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2024. LOT 2242202: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2022. EXPIRATION DATE: 2027-NOV-28. 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 CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (FROM 10MM TO 12MM) AND RESURFACED THE NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568977 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0210FR 2242202 07630971261280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention