BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE 02.18.003RM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM

    MDR report key: 18892568 · Received March 13, 2024

    Report

    Report Number
    3005180920-2024-00097
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 13, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895586
    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 16-FEB-2024. LOT 189249: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2019. EXPIRATION DATE: 2024-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: MOTO PARTIAL KNEE 02.18.TF4.RM TIBIAL TRAY FIX CEMENTED S4 RM (K162084) LOT 1904728: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2019. EXPIRATION DATE: 2024-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. MOTO PARTIAL KNEE 02.18.IF4.08.RM TIBIAL INSERT FIX S4 RM - 8MM (K162084) LOT 1903777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2019. EXPIRATION DATE: 2024-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED NEW PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135098 MOTO PARTIAL KNEE 02.18.003RM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED HSX MEDACTA INTERNATIONAL SA 189249 07630030895586

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention