BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERIKA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R E-CROSS

    MDR report key: 18301129 · Received December 11, 2023

    Report

    Report Number
    3005180920-2023-01001
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 11, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261884
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 NOVEMBER 2023. LOT 2201765: 25 ITEMS MANUFACTURED AND RELEASED ON 13-APR-2022. EXPIRATION DATE: 2027-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REV.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845710 GMK-SPHERIKA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2201765 07630971261884

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention