BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    MDR report key: 18482243 · Received January 10, 2024

    Report

    Report Number
    3005180920-2023-01088
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815751
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 JANUARY 2024. LOT 2212391: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JULY-2022. EXPIRATION DATE: 2027-07-11. 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 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE PATELLA IMPLANT MALTRACKING WITH IMPINGEMENT ON THE LATERAL SIDE OF THE FEMORAL IMPLANT. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987955 GMK-SPHERE PATELLA RESURFACING SIZE 2 KNEE PATELLA RESURFACING JWH MEDACTA INTERNATIONAL SA 2212391 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention