BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM COLLARED HA COATED STD STEM SIZE 4

    MDR report key: 7281745 · Received February 20, 2018

    Report

    Report Number
    3005180920-2018-00065
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    January 26, 2018
    Report Date
    February 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804595
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 16 FEBRUARY 2018: FEMORAL FRACTURE OCCURRED 3 DAYS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A 86 YEAR OLD PATIENT. NO TRAUMA WAS REPORTED. IMMEDIATE POSTOPERATIVE FRACTURES ARE KNOWN POSSIBLE ADVERSE EVENTS OF TOTAL HIP REPLACEMENTS. THEY MAY BE DUE TO THE NORMAL BONE WEAKENING CAUSED BY THE INTRAOPERATIVE FEMORAL PREPARATION AND FAVOURED BY BONE MORPHOLOGY AND MECHANICAL PROPERTIES. THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. BATCH REVIEW PERFORMED ON 19 FEBRUARY 2018: LOT 172626: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 OCTOBER 2017. EXPIRATION DATE: 2022-10-01. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THREE DAYS AFTER PRIMARY THE SURGEON DETECTED A FEMUR FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM AND THE HEAD WITH ANOTHER COMPANY'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125379 STEM COLLARED HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 172626 07630030804595

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention