BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 14201702 · Received April 26, 2022

    Report

    Report Number
    3005180920-2022-00290
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 26, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25-APR-2022. LOT 1905110: 150 ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2019. EXPIRATION DATE: 2024-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 148 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE INSERT WITH A 17 MM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541477 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 1905110 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention