BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 17867197 · Received October 4, 2023

    Report

    Report Number
    3005180920-2023-00776
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 SEPTEMBER 2023. LOT 2000398: 150 ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: 3 YEARS AFTER CEMENTED TKA ON A VERY LIGHTWEIGHT AND RATHER YOUNG FEMALE PATIENT, INSTABILITY AND ANTERIOR KNEE PAIN ARE DEVELOPED. FOR THIS REASON THE SURGEON DECIDED TO PROCEED TO SECONDARY RESURFACING OF THE PATELLA AND TO INCREASE THE INSERT THICKNESS, IN ORDER TO REESTABLISH JOINT TENSION AND IMPROVE STABILITY. BOTH THESE REASONS ARE TO BE ATTRIBUTED TO DISEASE PROGRESSION (INSTABILITY) OR DISEASE TO A DIFFERENT JOINT (PATELLO-FEMORAL) AND THEREFORE THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO KNEE INSTABILITY. THE SURGEON REVISED THE LINER (10 TO 14MM) WITH PATELLAR BONE RESURFACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526825 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2000398 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention