BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 0 STD

    MDR report key: 6431430 · Received March 24, 2017

    Report

    Report Number
    3005180920-2017-00122
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 22, 2017
    Report Date
    March 24, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 17 MARCH 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: HIP REVISION SURGERY OCCURRED 3 WEEKS AFTER PRIMARY THA. RADIOGRAPHIC IMAGES SHOW A SUBSIDED STEM. THE STEM LOOKS UNDERSIZED AND IN VARUS POSITION. THIS MAY BE DUE TO INDIVIDUAL PECULIARITIES OF THE PATIENT ANATOMY THAT CANNOT BE PERCEIVED BY THE SINGLE-VIEW X-RAY. THERE IS NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 20 MARCH 2017. LOT 150979: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 MAY 2015. EXPIRATION DATE: 2020-04-30. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN OVER THE HIP. AT X-RAY EXAMINATION IT WAS DISCOVERED THE STEM HAD SUBSIDED AND THE HIP WAS UNSTABLE. A REVISION SURGERY HAS BEEN PERFORMED. THE SURGEON STATED THAT THE X-RAYS CLEARLY SHOW PRIMARY STEM WAS UNDERSIZED, SO THIS IS A SURGEON ERROR, NOT IMPLANT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214775 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 0 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 150979

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention