BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/17 MM L

    MDR report key: 10539664 · Received September 16, 2020

    Report

    Report Number
    3005180920-2020-00608
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    August 15, 2020
    Report Date
    September 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826450
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15-SEP-2020LOT 2000397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2020. EXPIRATION DATE: 26-FEB-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 LINER 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004256 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/17 MM L FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0317FL 2000397 07630030826450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention