BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3

    MDR report key: 7506733 · Received May 11, 2018

    Report

    Report Number
    3005180920-2018-00323
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    April 13, 2018
    Report Date
    May 11, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802157
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 08 MAY 2018. REVISION DUE TO ASEPTIC LOOSENING OF THE STEM. STEM AND HEAD HAVE BEEN EXTRACTED COUPLED TOGETHER. FEMORAL STEM SHOWS SCRATCHES ON THE NECK DUE TO EXTRACTION PROCESS. THE HYDROXYAPATITE LAYER MISSING ON THE STEM INDICATES THE CONTACT AND BONE GROWTH REGIONS AND VICE VERSA. IN THIS ASYMMETRIC CONFIGURATION, IT IS POSSIBLE TO HYPOTHESIZE THE CAUSES OF ASEPTIC LOOSENING. BONE DEBRIS ARE STILL ATTACHED TO THE HYDROXYAPATITE LAYER. FEMORAL HEAD SHOWS A METAL SCRATCH PROBABLY DUE TO EXTRACTION PROCESS. BATCH REVIEW PERFORMED ON 09 MAY 2018; LOT 162220: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 JUNE 2016. EXPIRATION DATE: 2021-06-15 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE STEM LOOSENING AFTER ABOUT 2 YEARS FROM THE PRIMARY. THE STEM WAS IMPLANTED IN (B)(6) 2016 AND THE PATIENT RETURNED TO THE HOSPITAL WITH SIGNIFICANT STEM SUBSIDENCE AND STEM LOOSENING IN (B)(6) 2018. THE SURGEON REMOVED THE STEM AND HEAD USING THEN A COMPETITOR REVISION SYSTEM .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350642 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 162220 07630030802157

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention