BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20746293 · Received November 21, 2024

    Report

    Report Number
    3005180920-2024-00990
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261273
    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 11 NOVEMBER 2024: LOT 2339608: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2023. EXPIRATION DATE: 2028-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.3D02L 3DMETAL TIBIAL TRAY SIZE 2L (K221850) LOT 2302439: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA163L GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S3L (K223548) LOT 2343368: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2024. EXPIRATION DATE: 2029-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460239 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0210FL 2339608 07630971261273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention