BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    MDR report key: 9579974 · Received January 13, 2020

    Report

    Report Number
    3005180920-2019-01154
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    December 20, 2019
    Report Date
    January 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    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 27 DECEMBER 2019. LOT 1902481: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUN-2019. EXPIRATION DATE: 2024-05-27. 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, 1.5 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
    44920 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1902481 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention