BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    MDR report key: 8050710 · Received November 8, 2018

    Report

    Report Number
    3005180920-2018-00872
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 11, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    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 06 NOVEMBER 2018. LOT 181886: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MAY 2018. EXPIRATION DATE: 2023-05-13 NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON (B)(4) 2018 EARLY INFECTION IN CEMENTED TKA, 9 DAYS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 9 DAYS AFTER THE PRIMARY. THE PAIN WAS CAUSED DUE TO AN INFECTION (UNKNOWN PATHOGEN). AN I&D AND POLY-SWAP WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891483 TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 181886 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention