BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6126993 · Received November 24, 2016

    Report

    Report Number
    3005180920-2016-00605
    Event Type
    Injury
    Date Received
    November 24, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 24, 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

    ON 10 NOVEMBER 2016 THE PATIENT DEPARTMENT PROVIDED A PLANNING REVIEW AND COMMENTED AS FOLLOWS: OUR ANALYSIS OF THE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. BATCH REVIEW PERFORMED ON 21 NOVEMBER 2016. LOT 142499: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JULY 2014. EXPIRATION DATE: 2019-05-31. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN. NO TRAUMA TO THE PATIENT WAS MENTIONED. THE SURGEON REVISED THE INSERT AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777861 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 142499

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention