BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L

    MDR report key: 12223757 · Received July 26, 2021

    Report

    Report Number
    3005180920-2021-00648
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    August 2, 2017
    Report Date
    July 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862687
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 JULY 2021: LOT 112794: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN 2012. EXPIRATION DATE: 2016-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED.

    Description of Event or Problem · 1

    4 YEARS AND 2 MONTHS AFTER PRIMARY REVISION SURGERY FOR KNEE INSTABILITY. A THICKER LINER WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122205 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0611FL 112794 07630030862687

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention