BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC FEMORAL STEMS

    MDR report key: 20620132 · Received November 6, 2024

    Report

    Report Number
    3005180920-2024-00938
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885716
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A REVISION SURGERY WAS PERFORMED APPROXIMATELY 9 MONTHS AFTER THE PRIMARY IMPLANTATION OF A THA DUE TO STEM SUBSIDENCE. DESPITE THE LACK OF POST-OPERATIVE X-RAYS, THE AVAILABLE IMAGES CLEARLY SHOW THE STEM SUBSIDENCE. DETERMINING THE ROOT CAUSE OF THIS FAILURE IS CHALLENGING WITH THE CURRENT INFORMATION. POTENTIAL FACTORS MAY INCLUDE UNDERSIZING OF THE STEM, IMPROPER INITIAL POSITIONING OR POOR BONE QUALITY. NO DEFINITIVE CONCLUSIONS CAN BE DRAWN. BATCH REVIEW PERFORMED ON 23 OCTOBER 2024 LOT 1902845: 20 ITEMS MANUFACTURED AND RELEASED ON 04-JULY-2019. EXPIRATION DATE: 2024-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. THIS ISSUE MAY HAVE BEEN CAUSED BY THE UNDERSIZING OF THE STEM AND/OR PATIENT SPECIFIC FACTORS, BUT THE PRECISE CIRCUMSTANCES CANNOT BE CONFIRMED. ALTHOUGH NO DEFINITIVE ROOT CAUSE CAN BE CONFIRMED, THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO MASTERLOC STEM SUBSIDENCE, AT ABOUT 9 MONTHS FROM THE PRIMARY. THE SURGEON IMPLANTED AN AMIS-K WITH A CERAMIC HEAD. THE CUP NOT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428236 MASTERLOC FEMORAL STEMS HIP CEMENTLESS TI COATED STEM LZO MEDACTA INTERNATIONAL SA 01.39.211 1902845 07630030885716

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention