BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R

    MDR report key: 14346309 · Received May 10, 2022

    Report

    Report Number
    3005180920-2022-00346
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862670
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 APRIL 2022: LOT 1902508: (B)(4). EXPIRATION DATE: 2024-MAY-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376111 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0513FR 1902508 07630030862670

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention