BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    MDR report key: 8959607 · Received September 4, 2019

    Report

    Report Number
    3005180920-2019-00753
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    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 14 AUGUST 2019: LOT 171082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2017. EXPIRATION DATE: 2022-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE TIBIAL INSERT ALMOST 1 YEAR AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756568 TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 171082 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention