BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM L

    MDR report key: 11154580 · Received January 12, 2021

    Report

    Report Number
    3005180920-2021-00035
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826573
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: LOT 1910170: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JAN-2020. EXPIRATION DATE: 2024-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51923 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0412FL 1910170 07630030826573

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention