BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/20 MM R

    MDR report key: 10499302 · Received September 7, 2020

    Report

    Report Number
    3005180920-2020-00587
    Event Type
    Injury
    Date Received
    September 7, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826306
    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 (B)(4) 2020: LOT 173801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-NOV-2017. EXPIRATION DATE: 2022-11-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 1 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE SURGEON DECIDED TO RESURFACE THE PATIENT'S PATELLA. THE REASON FOR THIS ADDITIONAL PROCEDURE IS UNKNOWN. THE AGENT WAS NOT NOTIFIED OF THIS PROCEDURE UNTIL PRESENT AND A COMPLAINT WAS NOT FILED. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964674 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/20 MM R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.12.0220FR 173801 07630030826306

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention