BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

    MDR report key: 7518548 · Received May 16, 2018

    Report

    Report Number
    3005180920-2018-00330
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862618
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 MAY 2018. LOT 153317: 25 ITEMS MANUFACTURED AND RELEASED ON 20 OCTOBER 2015. EXPIRATION DATE: 2020-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 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 INFECTION WAS POSSIBLY CAUSED BY A TOOTH ABSCESS. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363157 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 153317 07630030862618

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention