BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM

    MDR report key: 9436672 · Received December 9, 2019

    Report

    Report Number
    3005180920-2019-01041
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    November 13, 2019
    Report Date
    December 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896774
    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 22 NOVEMBER 2019: LOT 160693: 61 ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2016. EXPIRATION DATE: 2021-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 60 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW MONTHS AFTER PRIMARY CEMENTED UKA THE ANTERIOR ASPECT OF THE TIBIAL BONE GAVE IN AND THE TIBIAL COMPONENT SUBSIDED AND MOBILIZED. REPORTEDLY, THIS WAS DUE TO THE PATIENT'S HYPOGONADISM AND POOR BONE QUALITY. NO REASON TO SUSPECT A FAULTY DEVICE TO BE RESPONSIBLE FOR THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    ABOUT 8 MONTHS AFTER PRIMARY REVISION SURGERY FOR TIBIAL IMPLANT SUBSIDENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY. ALL HARDWARE REVISED AND GMK-SPHERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235354 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM UNICOMPARTIMENTAL TIBIAL TRAY HSX MEDACTA INTERNATIONAL SA 160693 07630030896774

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention