BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 2 L

    MDR report key: 14547141 · Received May 31, 2022

    Report

    Report Number
    3005180920-2022-00425
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821387
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 APRIL 2022. LOT 113749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2012. EXPIRATION DATE: 2016-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT ON THE SAME LOT SINCE 2018. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. AT 6 YEARS AFTER REVISION TKA, THE FEMORAL COMPONENT MOBILIZES AND NEEDS REPLACEMENT. THE BONE OF THIS PATIENT LOOKS RATHER WEAK, THE CORTICES ARE THIN AND THE BONE DENSITY IN THE METAPHYSEAL DISTAL FEMOUR APPEARS TO BE LOW; THIS MAY DUE TO THE AGE OF THE LADY PATIENT. WE SEE NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS PROBLEM.

    Description of Event or Problem · 0

    AT 5 YEARS 8 MONTHS AFTER THE PRIMARY, REVISION SURGERY FOLLOWING THE LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL COMPONENT AND THE INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679608 GMK-REVISION FEMUR REVISION PS SIZE 2 L KNEE REVISION FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.2402L 113749 07630030821387

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention