BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9255108 · Received October 30, 2019

    Report

    Report Number
    3005180920-2019-00910
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    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 10 OCTOBER 2019: LOT 1901301: 60 ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 28 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 21 DAYS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA SPHERE INSERT FLEX LEFT 10MM S3 WITH A MEDACTA SPHERE INSERT FLEX LEFT 10MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052184 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1901301 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention