BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R

    MDR report key: 13768213 · Received March 15, 2022

    Report

    Report Number
    3005180920-2022-00187
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862663
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 FEBRUARY 2022: LOT 1905133: 25 ITEMS MANUFACTURED AND RELEASED ON 24-JULY-2019. EXPIRATION DATE: 2024-07-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AND 11 MONTHS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663873 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0511FR 1905133 07630030862663