BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L

    MDR report key: 14652250 · Received June 10, 2022

    Report

    Report Number
    3005180920-2022-00442
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-MAY-2022. LOT 1910648: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2020. EXPIRATION DATE: 2025-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: ONE YEAR AFTER PRIMARY TKA IN A SEVERELY VARUS PATIENT THE PATELLA DISLOCATES AND THE MEDIAL COLLATERAL LIGAMENT DEVELOPS INSTABILITY. IT IS THEREFORE NECESSARY TO REPLACE THE SYSTEM WITH A HIGHER-STABILITY DEVICE. THIS ADVERSE EVENT IS NOT RELATED TO A DEVICE DEFICIENCY, RATHER TO PROGRESSION OF DISEASE AND PATELLA PROBLEMS.

    Description of Event or Problem · 0

    PATELLA LUXATION AND MEDIAL LIGAMENT INSTABILITY 8 MONTHS AFTER THE PRIMARY SURGERY. THE FEMORAL COMPONENT WAS CHANGED TO A GMK REVISION SC WITH STEM, DISTAL 4MM AUGMENT AND A SC INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056503 GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0003L 1910648 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention