BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM L

    MDR report key: 10843094 · Received November 16, 2020

    Report

    Report Number
    3005180920-2020-00809
    Event Type
    Injury
    Date Received
    November 16, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862571
    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 OCTOBER 2020. LOT 162282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2016. EXPIRATION DATE: 2021-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 3 YEARS AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313129 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0313FL 162282 07630030862571

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention