BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    MDR report key: 14021281 · Received April 6, 2022

    Report

    Report Number
    3005180920-2022-00225
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    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 09 MARCH 2022: LOT 2001729: (B)(4) . EXPIRATION DATE: 2025-03-16. 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. THE SURGEON REVISED THE INSERT WITH A HIGHER ONE 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440477 TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0312FR 2001729 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention