BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 19892376 · Received August 2, 2024

    Report

    Report Number
    3005180920-2024-00589
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 18 JULY 2024: LOT 2201056: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2022. EXPIRATION DATE: 2027-03-09. 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 AFFAIR DIRECTOR: TWO YEARS AFTER PRIMARY TKA, INSTABILITY OF THE JOINT IS PERCEIVED BY THE PATIENT AND THE PATELLA TRACKING ACHIEVED AT PRIMARY SURGERY SEEMS TO HAVE BECOME SUBOPTIMAL. A THICKER INSERT IS USED FOR THE TIBIO-FEMORAL JOINT, AND THE CAUSE COULD SECONDARY LIGAMENT LAXITY. ALSO, RESURFACING OF THE PATELLA IS UNDERTAKEN, IN ORDER TO BETTER POSITION IT INSIDE THE PROSTHETIC TROCHLEA. NO REASON TO SUSPECT A FAULTY OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    REVISION DUE TO LATERALISED PATELLA AND INSTABILITY. AT ABOUT 1 YEAR AND 8 MONTHS POST PRIMARY PATELLAR BONE RESURFACING AND SOFT TISSUE RELEASE HAS BEEN PERFORMED TO CENTRALIZE THE PATELLA. INLAY CHANGE FROM 10 TO 14MM TO INCREASE THE STABILITY. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217067 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2201056

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention