BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE 02.18.002LM ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM

    MDR report key: 18901090 · Received March 14, 2024

    Report

    Report Number
    3005180920-2024-00116
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    February 13, 2024
    Report Date
    March 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895555
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2024. LOT 2012091: 11 ITEMS MANUFACTURED AND RELEASED ON 28-JAN-2021. EXPIRATION DATE: 2026-01-18. 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 REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: MOTO PARTIAL KNEE 02.18.IF3.08.LM TIBIAL INSERT FIX S3 LM - 8MM LOT. 2011114 (B)(6): 28 ITEMS MANUFACTURED AND RELEASED ON 04-JAN-2021. EXPIRATION DATE: 2025-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF3.LM TIBIAL TRAY FIX CEMENTED S3 LM LOT. 2012117 (B)(6): 50 ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2021. EXPIRATION DATE: 2026-02-23. 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 REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME REPORTING DISSATISFACTION WITH THE MOTO IMPLANTS. THE SURGEON REVISED SUCCESSFULLY THE COMPONENTS TO A TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077529 MOTO PARTIAL KNEE 02.18.002LM ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED HSX MEDACTA INTERNATIONAL SA 2012091 07630030895555

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention