BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L

    MDR report key: 10331334 · Received July 28, 2020

    Report

    Report Number
    3005180920-2020-00477
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862526
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JULY 2020: LOT 141410: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS STREPTOCOCCUS MITIS. THE SURGEON PERFORMED AN I & D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN, THE SURGEON PERFORMED AN I&D AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798326 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0211FL 141410 07630030862526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention