BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM LEFT

    MDR report key: 5932029 · Received September 7, 2016

    Report

    Report Number
    3005180920-2016-00456
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    August 8, 2016
    Report Date
    September 7, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 19 AUGUST 2016 AND INCLUDES: THE PATHOGEN IS (B)(6). BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 141422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2014. EXPIRATION DATE: 2019-03-31. 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. ON (B)(6) 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. 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
    585467 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141422

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention