BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 4

    MDR report key: 16538008 · Received March 14, 2023

    Report

    Report Number
    3005180920-2023-00140
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    February 13, 2023
    Report Date
    March 14, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815775
    PMA / PMN Number
    K113571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 FEBRUARY 2023. LOT: 2001621: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MARCH-2020. EXPIRATION DATE: 2025-03-13. 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

    AT ABOUT 2 YEARS AND 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO PATELLA FEMORAL PAIN. WHEN THE SURGEON EVALUATED THE PATIENT, HE DETERMINED THAT THE PATELLA HAD LOOSENED. THE SURGEON REVISED THE PATELLA, FEMUR, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016056 GMK-SPHERE PATELLA RESURFACING SIZE 4 KNEE PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0036RP 2001621 07630030815775

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention