BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R E-CROSS

    MDR report key: 18333496 · Received December 15, 2023

    Report

    Report Number
    3005180920-2023-01023
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 28, 2023
    Report Date
    December 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261327
    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 13 DECEMBER 2023. LOT 2012373: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2021. EXPIRATION DATE: 2026-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THEIR NATIVE PATELLA AND STIFFNESS. THE SURGEON RESURFACED THE NATURAL PATELLA AND REVISED THE INSERT (11 MM TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929143 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2012373 07630971261327

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention