BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/13 MM L

    MDR report key: 10572758 · Received September 23, 2020

    Report

    Report Number
    3005180920-2020-00648
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    August 29, 2020
    Report Date
    September 23, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862618
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT: LOT 1910171: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2019. EXPIRATION DATE: 2024-12-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 15 DAYS AFTER THE PRIMARY SURGERY AND IT WAS OBSERVED THAT A HEMATOMA HAD DEVELOPED. THE CAUSE OF THE HEMATOMA IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036529 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/13 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0413FL 1910171 07630030862618

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention