BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19086100 · Received April 11, 2024

    Report

    Report Number
    3005180920-2024-00241
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261754
    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 MARCH 2024: LOT 2309536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2023. EXPIRATION DATE: 2028-05-10. 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.

    Description of Event or Problem · 0

    AT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON UPSIZED THE LINER (FROM 10 MM TO 13 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262883 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS KNEE TIBIAL INSERT E-CROSS JWH MEDACTA INTERNATIONAL SA 2309536 07630971261754

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention