BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM RIGHT

    MDR report key: 5832913 · Received July 29, 2016

    Report

    Report Number
    3005180920-2016-00413
    Event Type
    Injury
    Date Received
    July 29, 2016
    Report Date
    November 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

    ADDITIONAL INFORMATION RECEIVED ON 06 OCTOBER 2016 AND INCLUDES: THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2016. THE SURGEON REMOVED THE SCREW AND REVISED THE INSERT. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 141027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MARCH 2014. EXPIRATION DATE: 2019-02-28. 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.

    Additional Manufacturer Narrative · 1

    ON (B)(6) IT WAS COMMUNICATED THAT THE AGENT BELIEVES A REVISION WILL TAKE PLACE WITHIN 4 WEEKS. A DATE HAS NOT BEEN SET. ON 28 JULY 2016 THE MEDICAL AFFAIRS DIRECTOR ANALYZED THE X-RAY WITH THE FOLLOWING COMMENTS: THE INSERT FIXATION SCREW IS SEEN TO HAVE BACKED OUT OF ITS SEATING. THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. IT IS STRONGLY RECOMMENDED THAT AN ARTHROSCOPICAL REMOVAL PROCEDURE BE UNDERTAKEN BEFORE THE LOOSE SCREW DAMAGES THE ARTICULAR SURFACES, PARTICULARLY OF THE FEMORAL COMPONENT, IF SUCH A PROCEDURE IS ADMISSIBLE FROM THE MEDICAL POINT OF VIEW. FROM THE POINT OF VIEW OF THE CLINICAL OUTLOOK, NO PROBLEM AT ALL SHOULD BE ANTICIPATED FOR AN INSERT BEING LEFT WITHOUT THE ADDITIONAL FIXATION SCREW. NOT EXPLANTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON NOTIFIED THAT THE SCREW BACKED OUT OF THE BASEPLATE. A REVISION HAS NOT BEEN SCHEDULED. X-RAYS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484826 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R