BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L

    MDR report key: 12216405 · Received July 23, 2021

    Report

    Report Number
    3005180920-2021-00628
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09-JUL-2021: LOT 1904545: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2019. EXPIRATION DATE: 2024-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    10 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116264 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.1203L 1904545 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention