BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L

    MDR report key: 10859602 · Received November 18, 2020

    Report

    Report Number
    3005180920-2020-00804
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 19, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862687
    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 27 OCTOBER 2020: LOT 180402: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018. EXPIRATION DATE: 2023-05-01. 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, 10 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323231 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0611FL 180402 07630030862687

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention