BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R

    MDR report key: 12777446 · Received November 9, 2021

    Report

    Report Number
    3005180920-2021-00868
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 OCTOBER 2021: LOT 2011069: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2020. EXPIRATION DATE: 2025-12-02. 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 · 0

    AT 24 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE 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
    1681630 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0310FR 2011069 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention