BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT

    MDR report key: 6060382 · Received October 27, 2016

    Report

    Report Number
    3005180920-2016-00545
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 27, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 160049: 25 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: (B)(6) 2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE PATIENT HAD A HEMATOMA. THE SURGEON REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710761 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 160049

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention