BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R

    MDR report key: 8095231 · Received November 21, 2018

    Report

    Report Number
    3005180920-2018-00929
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    October 23, 2018
    Report Date
    November 21, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826788
    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 21 NOVEMBER 2018: LOT 141033: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APR-2014. EXPIRATION DATE: 2019-02-28. 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 DUE TO SIGNS OF INFECTION 1 MONTH AND HALF AFTER PRIMARY SURGERY. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND A POLY SWAP "SUCCESFULLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936126 TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 141033 07630030826788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention