BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6157857 · Received December 9, 2016

    Report

    Report Number
    3005180920-2016-00649
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 12, 2016
    Report Date
    December 9, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 (B)(6) 2016. LOT 162283: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 06/22/2021. 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. THE INFECTION IS CONFIRMED AS (B)(6). THE SURGEON WASHED OUT THE KNEE AND SWAP THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808064 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 162283

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention