BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6

    MDR report key: 8310185 · Received February 6, 2019

    Report

    Report Number
    3005180920-2019-00024
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    January 7, 2019
    Report Date
    February 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803260
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 FEBRUARY 2019: LOT 181832: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2018. EXPIRATION DATE: 2023-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON JANUARY 25, 2019. FEMORAL HEAD REVISION FEW WEEKS AFTER TOTAL HIP ARTHROPLASTY. ACCORDING TO THE REPORT, THE STEM SUBSIDED BUT THIS CANNOT BE ASSESSED ON THE BASIS OF A SINGLE X-RAY. EARLY SUBSIDENCE MAY BE ASSOCIATED WITH INSUFFICIENT PRIMARY STABILITY ACHIEVED AT THE TIME OF OPERATION. NO CONCLUSION CAN BE DRAWN ON THE BASIS OF AVAILABLE INFORMATION, BUT THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A SUBSIDED STEM AFTER ABOUT 18 DAYS FROM PRIMARY. THE SURGEON CHOSE TO LEAVE THE STEM IN PLACE BUT REVISED HEAD AND ADDED A SLEEVE OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102716 MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6 CEMENTLESS ANATOMICAL STEM LZO MEDACTA INTERNATIONAL SA 181832 07630030803260

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R