BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK

    MDR report key: 11663062 · Received April 14, 2021

    Report

    Report Number
    3005180920-2021-00285
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802638
    PMA / PMN Number
    K082792
    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: DURING THE ANALYSIS IT IS EVALUATED THAT A LOT OF RESIDUAL OF HA COATING IS PRESENT ON THE STEM BODY, IN PARTICULAR ALMOST WHOLE PROXIMAL BODY IS COVERED WITH HA. IT IS CLEAR THAT THE STEM HAS NOT BEEN CORRECTLY OSSEOINTEGRATED WITH THE PATIENT BONE, AND THIS SHOULD BE THE CAUSE OF THE REPORTED PATIENT PAIN (STEM MOVEMENT). LOOKING AT THE STEM NECK AND TEAPER A LOT OF SCRATCHES AND SIGNS, TOGETHER WITH DEPP HOLES, ARE PRESENT, PROBABLY DUE TO THE DIFFICULT REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED NON-OSSEOINTEGRATION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 MARCH 2021. LOT 1903390: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-AUG-2019. EXPIRATION DATE: 2024-08-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DIRECTOR: ONE YEAR AFTER PRIMARY CEMENTLESS THA THE PATIENT FEELS PAIN AND REVISION IS PERFORMED. THE STEM IS FOUND ONLY PARTIALLY OSSEOINTEGRATED: REMOVAL IS DIFFICULT. FROM THE ATTACHED RADIOGRAPHS, PRONOUNCED AREAS OF RADIOLUCENCY CAN BE SEEN SINCE THE IMMEDIATE POSTOPERATIVE. THE ORIGIN OF THESE AREAS OF LOW DENSITY CANNOT BE DETERMINED, THEY MAY BE RESULTING FROM DIFFICULTIES ENCOUNTERED DURING PREPARATION OF THE FEMORAL CANAL, THOUGH THERE IS NO MENTION OF SUCH INCIDENT IN THE REPORT. THE ROOT CAUSE OF THIS ADVERSE EVENT CANNOT BE DETERMINED WITH THE INFORMATION AT HAND.

    Description of Event or Problem · 1

    FROM X-RAYS IT WAS RECOGNISED INSUFFICIENT OSSEOINTEGRATION OF THE STEM IN THE DISTAL PART, THE PATIENT HAD PAIN. THE SURGEON DECIDED TO REVISE THE PATIENT 1 YEAR 2 MONTHS AFTER THE PRIMARY. DURING THE SURGERY IT WAS HARD TO REMOVE THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560966 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.23SN 1903390 07630030802638

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention