BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE5/11 MM R

    MDR report key: 7726665 · Received July 27, 2018

    Report

    Report Number
    3005180920-2018-00574
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    July 5, 2018
    Report Date
    July 27, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862663
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 JULY 2018: LOT 163077: 25 ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2016. EXPIRATION DATE: 2021-07-21. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON JUL 6, 2018 WE WERE INFORMED THAT THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEAR AND 5 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. ON (B)(6) 2018 THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567698 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE5/11 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0511FR 163077 07630030862663

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention