BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R

    MDR report key: 9811087 · Received March 10, 2020

    Report

    Report Number
    3005180920-2020-00139
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 10, 2020
    Report Date
    March 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826221
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 FEBRUARY 2020: LOT 173799: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2017. EXPIRATION DATE: 2022-07-06. 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 REPORTING INSTABILITY IN THE KNEE. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 14MM S2 WITH THE MEDACTA SPHERE INSERT FLEX RIGHT 20MM S2. TO TIGHTEN THE KNEE 10 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274026 TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0214FR 173799 07630030826221

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention