BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM

    MDR report key: 15778664 · Received November 11, 2022

    Report

    Report Number
    3005180920-2022-00840
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    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 26 OCT 2022: LOT 161371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUN-2016. EXPIRATION DATE: 2021-MAY-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, 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
    2874557 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 161371 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention