BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 21033492 · Received December 30, 2024

    Report

    Report Number
    3005180920-2024-01096
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 9, 2024
    Report Date
    December 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896743
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10-DIC-2024. LOT: 170792: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-06-2017. EXPIRATION DATE: 2022-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 6 YEARS AND 1 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED TIBIAL COMPONENT. THE CAUSE OF THE SUBSIDED TIBIAL COMPONENT IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS FROM MOTO TO GMK-SPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437914 MOTO PARTIAL KNEE SYSTEM - MEDIAL TIBIAL TRAY FIXED CEMENTED S3 RM HSX MEDACTA INTERNATIONAL SA 02.18.TF3.RM 170792 07630030896743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention