BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 8270063 · Received January 23, 2019

    Report

    Report Number
    3005180920-2019-00006
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    December 27, 2018
    Report Date
    January 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 JANUARY 2019: LOT 180923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 MAY 2018. EXPIRATION DATE: 2023-04-29. 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, 86 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62502 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 180923 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention