BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM

    MDR report key: 13950874 · Received March 30, 2022

    Report

    Report Number
    3005180920-2022-00206
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 30, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895579
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 MARCH 2022. LOT 1910068: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: MOTO PARTIAL KNEE 02.18.TF4.LM TIBIAL TRAY FIX CEMENTED S4 LM ((B)(4)) LOT: 1910075: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2020. EXPIRATION DATE: 2025-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF4.08.LM TIBIAL INSERT FIX S4 LM - 8MM ((B)(4)) LOT: 2001397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2904989 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM KNEE UNICOMPARTIMENTAL FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 02.18.003LM 1910068 07630030895579

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention