BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18613587 · Received January 31, 2024

    Report

    Report Number
    3005180920-2024-00017
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 31, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827143
    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 08 JANUARY 2024: LOT 2210623: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2022. EXPIRATION DATE: 2027-AUG-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: ONE YEAR AFTER PRIMARY CEMENTED TKA, THE PATIENT COMPLAINS ABOUT ANTERIOR KNEE PAIN. THE PATELLA HAD NOT BEEN RESURFACED. WE UNDERSTAND THAT THE MAIN CAUSE FOR FURTHER SURGERY WAS THE NEED TO TREAT THE PATELLO-FEMORAL JOINT, SO WE WOULD CONSIDER IT DISEASE PROGRESSION. HOWEVER, ONCE THE JOINT WAS OPENED, SOME DOUBTS AROSE ABOUT THE STABILITY OF THE TIBIAL COMPONENT, AND THEY DECIDED TO EXCHANGE IT TO A NEW ONE. FROM THE RADIOGRAPHS SUPPLIED, WE CANNOT DETECT A MOBILIZATION OF THE TRAY OR A DEFECT IN THE IMPLANTATION, SO WE ASSUME THAT THE EXCHANGE HAS BEEN CARRIED OUT FOR PRUDENCE, A THOROUGHLY UNDERSTANDABLE DECISION. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR PAIN DUE TO LOOSENING OF THE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND RESURFACED THE NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246744 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2210623 07630030827143

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention