BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FLEX SIZE 4/10 MM LEFT

    MDR report key: 5446929 · Received February 19, 2016

    Report

    Report Number
    3005180920-2016-00052
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    January 21, 2016
    Report Date
    May 19, 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 19 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2016. LOT 141793: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 19 FEB 2016 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING COMMENT: ACCORDING TO REPORT, THE TKR HAD BEEN PERFORMED TOO TIGHTLY ONE AND HALF YEAR BEFORE REOPERATION. AS THE THINNEST INSERT HAD BEEN USED, REOPERATION CONSISTED IN LIGAMENT RELEASE ONLY. THERE IS NO REASON TO SUSPECT THAT SUCH SITUATION WAS INDUCED BY A DEFECT INTRINSIC TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    THE PATIENT CAME IN WITH TIGHTNESS OF THE KNEE DURING FLEXION AND EXTENSION. THE SURGEON OPENED THE PATIENT'S KNEE AND STRETCHED THE SOFT TISSUE INCLUDING THE PCL. SINCE THE PATIENT HAD A 10MM INSERT THE SURGEON COULD NOT DECREASE THE SIZE OF THE INSERT BUT FELT THE STRETCHING HE PREFORMED INCREASED THE PATIENT'S KNEE MOBILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE X-RAYS MAY BE AVAILABLE. THE EXPLANT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103628 GMK-SPHERE TIBIAL INSERT FLEX SIZE 4/10 MM LEFT FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 141793

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention