BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21102279 · Received January 8, 2025

    Report

    Report Number
    3005180920-2024-01117
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261808
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17-DIC-2024: LOT: 2401139: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-02-2024. EXPIRATION DATE: 2029-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER INFECTION, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869643 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERIKA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0411FR 2401139 07630971261808

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention