BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/14 MM LEFT

    MDR report key: 5690869 · Received June 1, 2016

    Report

    Report Number
    3005180920-2016-00252
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    April 28, 2016
    Report Date
    August 4, 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

    ON 27 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY REPORTED IN THE INITIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON (B)(6) 2016: LOT 141016: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 MAY 2014. EXPIRATION DATE: 2019-04-30. 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. GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/13 MM RIGHT, CODE 02.12.0311FR, LOT 152934 ((B)(4)), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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 HAD A PRIMARY BILATERAL KNEE ON (B)(6) 2016. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. ON (B)(6) 2016 THE SURGEON PERFORMED AN INCISION AND DRAINAGE AND SWAPPED THE POLY ON BOTH LEFT AND RIGHT KNEES. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS AND X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345686 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/14 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention