BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S1 RM

    MDR report key: 9494688 · Received December 19, 2019

    Report

    Report Number
    3005180920-2019-01088
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895548
    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 06 DECEMBER 2019: LOT 170777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2017. EXPIRATION DATE: 2022-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BATCH REVIEWS PERFORMED ON 06 DECEMBER 2019. MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM (K162084) LOT 182138: 32 ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2018. EXPIRATION DATE: 2023-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.TF2.RM TIBIAL TRAY FIX CEMENTED S2 RM (K162084) LOT 184276: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2018. EXPIRATION DATE: 2023-09-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE PARTIAL KNEE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT AND CONVERTED THEM TO TOTAL KNEE COMPONENTS 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288281 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S1 RM KNEE FENORAL IMPLANT HSX MEDACTA INTERNATIONAL SA 170777 07630030895548

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention