BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 12

    MDR report key: 10009048 · Received April 29, 2020

    Report

    Report Number
    3005180920-2020-00260
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    March 31, 2020
    Report Date
    April 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040715843
    PMA / PMN Number
    K173267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 3 APRIL 2020: LOT 180719: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2018. EXPIRATION DATE: 2023-05-02. 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: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FEMORAL FRACTURE. A SUBCLINIC INTRAOPERATIVE FRACTURE IS PROBABLY THE CAUSE OF THIS EVENT BUT ALSO A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    6 WEEKS AFTER THE PRIMARY THE PATIENT CAME IN WITH PAIN AND THE X-RAY REVEALED PERIPROSTHETIC FRACTURE ( PROBABLY OCCURRED DURING THE PRIMARY SURGERY). THE STEM WAS REVISED AND THE FRACTURE WAS CABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473016 STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 12 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.39.412 180719 07630040715843

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention