BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM R

    MDR report key: 11770208 · Received May 4, 2021

    Report

    Report Number
    3005180920-2021-00357
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 4, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862540
    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 03-MAY-2021: LOT 1901313: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2019. EXPIRATION DATE: 2024-05-19. 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

    REVISION SURGERY PERFORMED DUE TO INFECTION AFTER ABOUT 1 MONTH FROM THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT ALREADY UNDERWENT REVISION SURGERY, IT WAS DUE TO THE TIBIAL TRAY SUBSIDENCE, THIS HAPPENED ABOUT 1 MONTH AGO, WITH RESPECT TO THIS SURGERY. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND ADDED A FLUTED EXTENSION STEM AND TIBIAL AUGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665166 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0211FR 1901313 07630030862540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention