BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 3

    MDR report key: 7888909 · Received September 19, 2018

    Report

    Report Number
    3005180920-2018-00694
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    August 23, 2018
    Report Date
    September 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE 26 AUGUST 2018: THE HEAD WAS DISLOCATING FROM LINER. SECOND REVISION SURGERY OCCURRED ON (B)(4) 2018 TO FIX RECURRENT DISLOCATION, LINER EXPLANTED. BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2018; LOT 153422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 SEPTEMBER 2015. EXPIRATION DATE: 2020-09-08; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT LINER CC E CC LIGHT FLAT PE HC LINER Ø 36 / E REFERENCE 01.26.3644HCT; LOT 156435: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 FEBRUARY 2016. EXPIRATION DATE: 2021-01-23; 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 (B)(4) ON 18 SEPTEMBER 2018 POLYETHYLENE LINER EXCHANGE DUE TO RECURRENT DISLOCATION 2 YEARS AFTER FIRST REVISION FOR FEMORAL FRACTURE. THE POLYETHYLENE INSERT WAS EXCHANGE DUE TO SIZE MATCHING AND AS PER STANDARD PROCEDURE, NOT BECAUSE OF A MALFUNCTION. THE FEMORAL COMPONENTS ARE NOT OBJECT OF THIS INVESTIGATION BECAUSE PROCEEDING FROM DIFFERENT MANUFACTURER.

    Description of Event or Problem · 1

    ON 20 AUGUST 2018 WE WERE INFORMED THAT A PRIMARY SURGERY (B)(6) 2016, REVISED ON (B)(6) 2016 FOR PERIPROSTHETIC FRACTURE OF FEMUR, PATIENT NOW REQUIRES SECOND REVISION SURGERY FOR RECURRENT DISLOCATION. ON (B)(6) 2018 WE WERE INFORMED THAT VERSAFIT LINER WAS REMOVED. THE CASE WAS COMPLETED SUCCESSFULLY AND THE HIP NO LONGER DISLOCATES AND IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729554 AMISTEM H HA COATED STD STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 153422 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention