BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM

    MDR report key: 12867456 · Received November 24, 2021

    Report

    Report Number
    3005180920-2021-00929
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896743
    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 04 NOVEMBER 2021: LOT 170792: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2017. EXPIRATION DATE: 2022-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 04 NOVEMBER 2021: MOTO PARTIAL KNEE 02.18.003RM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM (K162084) LOT 1908730: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2019. EXPIRATION DATE: 2024-11-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EV. MOTO PARTIAL KNEE 02.18.IF3.09.RM TIBIAL INSERT FIX S3 RM - 9MM (K162084) LOT 178558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MARCH-2018. EXPIRATION DATE: 2023-03-07. 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 5 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING FLEXION INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT TO A TOTAL KNEE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765430 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM CEMENTED TIBIAL TRAY HSX MEDACTA INTERNATIONAL SA 02.18.TF3.RM 170792 07630030896743

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention