BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM

    MDR report key: 18011664 · Received October 26, 2023

    Report

    Report Number
    3005180920-2023-00840
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896095
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2023 LOT 2219899: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2022. EXPIRATION DATE: 2027-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 OCTOBER 2023. MOTO PARTIAL KNEE 02.18.IF4.08.LLRL TIBIAL INSERT FIX S4 - LATERAL - 8MM (K183029) LOT 2215654: 16 ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2022. EXPIRATION DATE: 2027-09-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON THE (B)(6) 2023: A REOPERATION WAS CONDUCTED 1 YEAR AFTER THE PRIMARY IMPLANT OF A BI-MONOCOMPARTMENTAL KNEE ARTHROPLASTY (MOTO MEDIAL AND MOTO LATERAL). THE REPORTED CASUSE IS A PURULENT ARTHRITIS, FOR WHICH A SCRAPING PROCEDURE WAS CONDUCTED. INFECTION IS A POSSIBLE COMPLICATION OF KNEE SURGERY AND A DELAYED ONSET (SUCH IN THIS CASE) IS WIDELY DESCRIBED IN THE LITERATURE. ON THE AVAILABLE X-RAYS, THERE ARE DOUBTFUL SIGNS OF BONY ALTERATION IN THE PROXIMAL TIBIA (ESPECIALLY ON THE LATERAL SIDE). HOWEVER THE SURGEON EVALUATED THE IMPLANT STABLE, CHANGING ONLY THE INSERTS. WE HAVE NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 11 MONTHS AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED INFECTION. AT THE TIME OF PURULENT ARTHRITIS SCRAPING, BOTH INSERTS (MOTO MEDIAL-LATERAL) WERE SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000740 MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM KNEE TIBIAL INSERT HSX MEDACTA INTERNATIONAL SA 2219899 07630030896095

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention