BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S6 LM

    MDR report key: 9961388 · Received April 15, 2020

    Report

    Report Number
    3005180920-2020-00246
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 19, 2019
    Report Date
    April 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896798
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 APRIL 2020: LOT 182129: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-06-19. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: LESS THAN 1 YEAR AFTER UKA, THE TIBIAL COMPONENT GETS LOOSE AND THE JOINT REQUIRES REVISION, PROBABLY TO TKA. ONLY ONE RADIOGRAPHIC IMAGE IS SUPPLIED, FROM WHICH THE TIBIAL COMPONENT LOOKS IN SUBOPTIMAL POSITION - WE HAVE NO HISTORY, HENCE WE DO NOT KNOW IF THIS POSITION WAS CHOSEN AT THE TIME OF INDEX SURGERY OR IF IT IS THE RESULT OF MIGRATION. THE LATERAL VIEW AND THE POSTOPERATIVE IMAGES COULD HAVE HELPED TO BETTER UNDERSTAND. WE HAVE NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT 10 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425500 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S6 LM KNEE TIBIAL TRAY HSX MEDACTA INTERNATIONAL SA 02.18.TF6.LM 182129 07630030896798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention