BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0510CRR TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM R

    MDR report key: 14588475 · Received June 3, 2022

    Report

    Report Number
    3005180920-2022-00428
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 7, 2022
    Report Date
    June 3, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707626
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 MAY 2022. LOT 2112403: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-OCT-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AND 1 WEEK AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032166 GMK-SPHERE 02.12.0510CRR TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM R KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0510CRR 2112403 07630040707626

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention