BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 RM

    MDR report key: 16917557 · Received May 12, 2023

    Report

    Report Number
    3005180920-2023-00323
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896767
    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 13 APRIL 2023: LOT 2103556: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2021. EXPIRATION DATE: 2026-05-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: LESS THAN 2 YEARS AFTER UKA, THE TIBIAL COMPONENT CREATES PAIN AND REQUIRES SUBSTITUTION. ACCORDING TO REPORT, THERE MAY HAVE BEEN A PROBLEM BETWEEN BONE AND CEMENT. A FEEBLE RADIOLUCENT LINE IS BARELY VISIBLE BENEATH THE TIBIAL PLATEAU. THE POOR INTERDIGITATION OF CEMENT TO BONE IS A PLAUSIBLE CAUSE FOR MOBILIZATION BUT IT CAN HARDLY BE DEBITED TO A FAULTY DEVICE. PRELIMINARY INVESTIGATION PERFORMED BY R&D DEPARTMENT:: REVISION SURGERY OF A MOTO MEDIAL IMPLANT AFTER 1 YEAR AND 7 MONTHS FROM PRIMARY IMPLANTATION DUE TO SUSPECTED TIBIA LOOSENING. FROM PICTURE OF THE EXPLANTED COMPONENTS. NO ANOMALIES CAN BE NOTED. RESIDUAL CEMENT CAN BE SEEN ON THE IMPLANTS, SO PROBABLY THE CEMENT DIDN'T ADHERE PROPERLY TO THE BONE. THERE IS NO EVIDENCE TO SUSPECT THAT THE LOOSENING WAS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 1 YEAR AND 7 MONTHS POST PRIMARY FOR CEMENTED TIBIAL TRAY LOOSENING. ALL COMPONENTS REVISED AND GMK SPHERE WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652674 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 RM KNEE PARTIAL SYSTEM CEMENTED TIBIAL TRAY HSX MEDACTA INTERNATIONAL SA 02.18.TF4.RM 2103556 07630030896767

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention