BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6621617 · Received June 8, 2017

    Report

    Report Number
    3005180920-2017-00285
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 9, 2017
    Report Date
    June 8, 2017
    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

    ADDITIONAL INFORMATION RECEIVED ON 15 MAY 2017 AND INCLUDES: THE SURGEON REVISED A SIZE 412MM GMK-SPHERE INSERT AND IMPLANTED A SIZE 4 11MM GMK-SPHERE INSERT. BATCH REVIEW PERFORMED ON 07 JUNE 2017. LOT 163073: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2016. EXPIRATION DATE: 2021-07-25. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO ABNORMAL BLEEDING. THE CAUSE OF THE ABNORMAL BLEEDING IS UNKNOWN. THE SURGEON REVISED 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
    407958 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 163073

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention