BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM RIGHT

    MDR report key: 6314102 · Received February 9, 2017

    Report

    Report Number
    3005180920-2017-00028
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    January 10, 2017
    Report Date
    February 9, 2017
    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(B)(6) 2017 THE PATIENT MATCHED DEPARTMENT PERFORMED THE REVIEW OF THE CASE WITH THE FOLLOWING COMMENTS: WE DID NOT RECEIVE ANY X-RAY, THEREFORE NO EXTRA ANALYSIS IS POSSIBLE. OUR ANALYSIS OF THE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. ALL THE STEPS HAVE BEEN PERFORMED CORRECTLY. BATCH REVIEW PERFORMED ON 06 FEBRUARY 2017. LOT 162638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JULY 2016. EXPIRATION DATE: 2021-07-14. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON REVISED THE 10MM INSERT FOR A 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99795 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 162638

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention