BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 11087667 · Received December 29, 2020

    Report

    Report Number
    3005180920-2020-00951
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 1, 2020
    Report Date
    February 18, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D DEPARTMENT: VISUAL INSPECTION PERFORMED ON 19TH JANUARY 2021. NO PARTICULAR SIGNS WERE NOTICED ON THE STEM AND HEAD; SOME LITTLE SIGNS ON THE SPHERICAL SURFACE OF THE CERAMIC BALL HEAD ARE PROBABLY RELATED TO THE REVISION SURGERY, WHILE THE STEM WAS COMPLETELY UNCOVERED FROM HA, INDICATOR OF PROPER OSSEOINTEGRATION. FROM THE RECEIVED INFORMATION THE ROOT CAUSE OF THE EVENT REMAINS UNKNOWN, BUT ASEPTIC LOOSENING IS COMMON BETWEEN THE ADVERSE EVENTS DESCRIBED IN LITERATURE AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 DECEMBER 2020 LOT 140745: 100 ITEMS MANUFACTURED AND RELEASED ON 23-APR-2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED SINCE 2016.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A REVISION (6 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY) ON THE RIGHT HIP OF THE PATIENT DUE TO AN ASEPTIC LOOSENING. STEM AND HEAD HAVE BEEN SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553321 STEM: AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 140745 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention