BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/17 MM LEFT

    MDR report key: 6947207 · Received October 13, 2017

    Report

    Report Number
    3005180920-2017-00581
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826856
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 152439: 25 ITEMS MANUFACTURED AND RELEASED ON 02 NOVEMBER 2015. EXPIRATION DATE: (B)(6) 2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 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 INFECTION. THE PATHOGEN IS UNKNOWN. 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
    728443 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/17 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 152439 07630030826856

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention