BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FLEX TIBIAL INSERT SIZE 4 / 14 MM RIGHT

    MDR report key: 5117173 · Received October 1, 2015

    Report

    Report Number
    3005180920-2015-00215
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    September 1, 2015
    Report Date
    December 22, 2015
    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) 2015. LOT 123219: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: 2017-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE. UPDATE RECEIVED ON SEP, 8TH 2015: THE SALES AGENT INFORMED US THAT THEY WILL NOT GIVE US THE PATHOLOGY REPORT. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 30 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT WENT INTO THE EMERGENCY ROOM COMPLAINING OF PAIN. THE SURGEON PREFORMED AN I & D AND REPLACED THE LINER. EXPLANTS WILL NOT BE AVAILABLE FOR ANALYSIS. X-RAYS WILL NOT BE AVAILABLE. WAITING TO SEE IF PATHOLOGY RESULTS WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650632 GMK SPHERE FLEX TIBIAL INSERT SIZE 4 / 14 MM RIGHT FIXED PE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 123219

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention