BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM R

    MDR report key: 9334635 · Received November 18, 2019

    Report

    Report Number
    3005180920-2019-00966
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 19, 2019
    Report Date
    November 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862588
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 OCTOBER 2019: LOT 1900410: 90 ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2019. EXPIRATION DATE: 2024-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 11MM S3 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 11MM S3, 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133114 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1900410 07630030862588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention