BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20469761 · Received October 17, 2024

    Report

    Report Number
    3005180920-2024-00830
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261914
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25-SEP-2024: LOT 2318208: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-AUG-2023. EXPIRATION DATE: 2028-07-24. 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. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 25-SEP-2024: GMK-SPHERIKA 02.12.KA14L FEMORAL COMPONENT SPHERIKA CEMENTED S4+L (K211004) LOT 2408295: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2024. EXPIRATION DATE: 2029-06-13. 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 MEDACTA MEDICAL AFFAIRS DIRECTOR: 2 DAYS AFTER PRIMARY TKA THE PATIENT FLEXES THE KNEE EXCESSIVELY AND DISLOCATION OCCURS. SUCH AN EVENT INDICATES THAT MOST PROBABLY THE COLLATERAL LIGAMENTS RUPTURED OR WERE IN A STATE OF SEVERE INSUFFICIENCY. FOR THIS REASON, THE SURGEON DECIDED TO REPLACE THE FORMER PROSTHESIS WITH A CONSTRAINED DEVICE. NO REASON TO SUSPECT A FAULTY IMPLANT AT THE ORIGIN OF THIS REOPERATION.

    Description of Event or Problem · 0

    TWO DAYS AFTER THE PRIMARY KNEE SURGERY, THE PATIENT HAS BEEN REVISED BECAUSE, THE DAY AFTER THE PRIMARY THE PATIENT PULLED HER KNEE IN AN ATTEMPT TO ACHIEVE MAXIMUM FLEXION AND KNEE LUXATION OCCURRED (FEMORAL COMPONENT FROM LINER). THE SURGEON REVISED ALL COMPONENTS TO GMK-HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202418 GMK SPHERE TOTAL KNEE SYSTEM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.E0414FL 2318208 07630971261914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention