BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    MDR report key: 15657369 · Received October 24, 2022

    Report

    Report Number
    3005180920-2022-00799
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    October 3, 2022
    Report Date
    October 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862410
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 OCTOBER 2022: LOT 2000509: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2020. EXPIRATION DATE: 2025-03-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 2013144: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2021. EXPIRATION DATE: 2026-07-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING AND THE CAUSE IS UNKNOWN. ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS EXCEPT THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2804596 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0025L 2000509 07630030862410

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention