BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R

    MDR report key: 12860791 · Received November 23, 2021

    Report

    Report Number
    3005180920-2021-00896
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    October 24, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862540
    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 28 OCTOBER 2021. LOT 1901313: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUNE-2019. EXPIRATION DATE: 2024-MAY-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT [EMDR 2021-00357].

    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, 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
    1763414 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0211FR 1901313 07630030862540

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention