BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER

    MDR report key: 11017686 · Received December 16, 2020

    Report

    Report Number
    3005180920-2020-00939
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    November 25, 2020
    Report Date
    December 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630040720694
    PMA / PMN Number
    K183029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 DECEMBER 2020: LOT 1906794: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2019. EXPIRATION DATE: 2024-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEWS PERFORMED ON 04 DECEMBER 2020: MOTO PARTIAL KNEE 02.18.IF6.08.LLRL TIBIAL INSERT FIX S6 - LATERAL - 8MM (K183029) LOT 1906756: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.TF6.RL TIBIAL TRAY FIX CEMENTED S6 RL (K183029) LOT 1906787: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, ONE MONTH AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO OSTEOPOROSIS. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481430 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER KNEE FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 1906794 07630040720694

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention