BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L

    MDR report key: 7964626 · Received October 15, 2018

    Report

    Report Number
    3005180920-2018-00786
    Event Type
    Injury
    Date Received
    October 15, 2018
    Date of Event
    September 15, 2018
    Report Date
    October 15, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826573
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018. LOT 170299: 50 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: 2022-04-09 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 8 MONTH AFTER PRIMARY SURGERY DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807152 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 170299 07630030826573

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention