BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R

    MDR report key: 7677506 · Received July 11, 2018

    Report

    Report Number
    3005180920-2018-00488
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    June 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826146
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2018. LOT 160153: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MAY 2016. EXPIRATION DATE: 2021-04-21 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY 1 YEAR AND 9 MONTHS AFTER PRIMARY. THE SURGEON BELIEVES THE JOINT STRETCHED OVER TIME. THE SURGEON REVISED THE 10MM POLY FOR A 13MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519325 TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 160153 07630030826146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention