BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM

    MDR report key: 11307550 · Received February 10, 2021

    Report

    Report Number
    3005180920-2021-00105
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    January 13, 2021
    Report Date
    February 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895609
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JANUARY 2021: LOT 167877: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2017. EXPIRATION DATE: 2022-02-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2017. ANOTHER IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 25 JANUARY 2021: MOTO PARTIAL KNEE 02.18.TF5.RM TIBIAL TRAY FIX CEMENTED S5 RM (K162084)LOT. 160695: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2016. EXPIRATION DATE: 2021-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, AL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2017. BATCH REVIEW PERFORMED ON 25 JANUARY 2021: MOTO PARTIAL KNEE 02.18.IF5.08.RM TIBIAL INSERT FIX S5 RM - 8MM (K162084)LOT. 161214: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2016. EXPIRATION DATE: 2021-06-01. 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 SINCE 1-1-2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE OF THE PAIN AND INSTABILITY WAS DUE TO LIGAMENTS THAT HAD LOOSENED OVER TIME. 3 YEARS AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202952 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM KNEE FEMORAL CEMENTED PROSTHESIS HSX MEDACTA INTERNATIONAL SA 02.18.004RM 167877 07630030895609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention