BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM

    MDR report key: 14545852 · Received May 31, 2022

    Report

    Report Number
    3005180920-2022-00407
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 2, 2022
    Report Date
    July 14, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896705
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 MAY 2022: LOT 182120: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JULY-2018. EXPIRATION DATE: 2023-06-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. FEW MONTHS AFTER PRIMARY UKA IN A LARGELY OVERWEIGHT PATIENT, THE TIBIAL BONE GIVES WAY AND THE BASEPLATE SUBSIDES. SUBSTITUTION TO A TOTAL KNEE BECOMES NECESSARY. THIS INCONVENIENCE WAS NOT RELATED TO A DEVICE DEFECT OR MALFUNCTION.

    Additional Manufacturer Narrative · 0

    DEVICES NOT AVAILABLE ANYMORE, AS REPORTED BY THE SALES AGENT ON 14 JUNE 2022.

    Description of Event or Problem · 0

    REVISION SURGERY AT 7 MONTHS FROM PRIMARY FOR TIBIAL IMPLANT SUBSIDENCE. THE SUBSIDENCE IS LIKELY DUE TO PATIENT WEIGHT AND INSUFFICIENT BONE STABILITY. ALL IMPLANTS WERE REVISED AND GMK SPHERE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599052 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM KNEE UNICOMPARTIMENTAL TIBIAL TRAY CEMENTED HSX MEDACTA INTERNATIONAL SA 02.18.TF1.RM 182120 07630030896705

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention