BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX CEMENTLESS FEMORAL STEM

    MDR report key: 7142941 · Received December 22, 2017

    Report

    Report Number
    3005180920-2017-00767
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 22, 2017
    Report Date
    January 18, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803291
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018 THE R&D PROJECT MANAGER CHECKED THE EXPLANT DEVICE COMMENTING AS FOLLOWING: THE MINIMAX STEM WAS ANALYZED. THE SURFACE SHOWED THE COATING ABSORBED IN SOME AREAS, ESPECIALLY IN EXTRADOX AND INTRADOX, WHERE THE MAXIMUM CONTACT IS SUPPOSED TO BE FORM THE X-RAYS IMAGE. NO OTHER PARTICULAR SIGNS WERE NOTICED, AND FROM THE RECEIVED PIECE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: EARLY SUBSIDENCE OF AN ANATOMIC CEMENTLESS STEM IN PRIMARY THR. EVIDENCE OF SIGNIFICANT FRACTURE CAN BE DRAWN FROM THE RADIOGRAPHS SUPPLIED; NO MENTION OF TRAUMATIC EVENTS. THE REASON FOR THE FRACTURE AND THE SUBSIDENCE IS NOT KNOWN, NOR CAN WE DETERMINE WHICH HAPPENED FIRST. ONE POSSIBILITY IS THE INSERTION OF AN UNDERSIZED STEM THAT WAS UNABLE TO FIND SUFFICIENT STABILITY, BUT OF COURSE OTHER REASONS MAY APPLY. BATCH REVIEW PERFORMED ON (B)(6) 2017, LOT 160265: 16 ITEMS MANUFACTURED AND RELEASED ON 18 MAY 2016. EXPIRATION DATE: (B)(6) 2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    FOLLOWING THE PRIMARY SURGERY THE REVIEW OF THE PATIENT DISCOVERED THAT THE STEM HAD SUBSIDED AND A GREATER TROCHANTERIC FRACTURE WAS PRESENT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY USING A REVISION STEM AND CABLES. AS THE ACETABULUM IS A DM CUP A NEW LINER AND CERAMIC HAD WAS ALSO IMPLANTED. ALTHOUGH SUBSIDED, THE STEM DISPLAYED EXCELLENT ON-GROWTH AND STABILITY WITHIN THE CANAL AS SUCH IT WAS DIFFICULT TO EXPLANT. THE CUP WAS NOT TOUCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922096 MINIMAX CEMENTLESS FEMORAL STEM CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 160265 07630030803291

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention