BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2

    MDR report key: 19719882 · Received July 11, 2024

    Report

    Report Number
    3005180920-2024-00501
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803185
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 JUNE 2024. LOT 2201588: 10 ITEMS MANUFACTURED AND RELEASED ON 13-06-2022. EXPIRATION DATE: 2027-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY (B)(4). SECOND REVISION 3 MONTHS AFTER THE FIRST REVISION DUE TO JOINT INSTABILITY AND STEM MOBILIZATION. FROM THE ONLY IMAGE PROVIDED, THE STEM APPEARS UNDERSIZED AND IN A VALGUS POSITION AND FOR THESE REASONS THE SURGEON DECIDED TO EXCHANGE IT TO A LARGER COLLARED STEM AFTER RESTORING JOINT TENSION BY CHANGING THE HEAD. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. PRELIMINARY ANALYSIS PERFORMED BY R&D PROJECT MANAGER. LOOKING AT THE IMAGES ATTACHED TO THE COMPLAINT IT IS VISIBLE THE EXPLANTED STEM COVERED WITH PATIENT BLOOD. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED FAILURE FROM THIS IMAGE.

    Description of Event or Problem · 0

    MINIMAX STEM MOBILIZED AND ROTATED IN THE PATIENT'S FEMUR. STEM AND HEAD REVISED AT ABOUT 3 MONTHS FROM THE PREVIOUS REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384935 STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2 HIP CEMENTLESS ANATOMICAL STEM LZO MEDACTA INTERNATIONAL SA 2201588 07630030803185

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention