BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R

    MDR report key: 7549096 · Received May 29, 2018

    Report

    Report Number
    3005180920-2018-00383
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 29, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826184
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 MAY 2018; LOT 143385: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2014. EXPIRATION DATE: 2019-04-30 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ABOUT TWO YEARS AFTER PRIMARY. THE SURGEON NOTICED A DEFECT UNDER THE TIBIAL IMPLANT WHICH THE SURGEON PACKED WITH ANTIBIOTIC BEADS. THE SURGEON PERFORMED AN I & D AND A POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATHOGEN WAS STAPHYLOCOCCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392084 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 143385 07630030826184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention