BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20746292 · Received November 21, 2024

    Report

    Report Number
    3005180920-2024-00962
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    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 31-OCT-2024: LOT 2201173: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2022. EXPIRATION DATE: 2027-03-28. 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. ADDITIONAL DEVICE REVISED BATCH REVIEW PERFORMED ON 31-OCT-2024 GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L (K121416) LOT 2119138: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2022. EXPIRATION DATE: 2027-02-24. 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

    AT ABOUT 2 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460238 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L JWH MEDACTA INTERNATIONAL SA 02.12.0024L 2201173 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention