BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2

    MDR report key: 9932759 · Received April 7, 2020

    Report

    Report Number
    3005180920-2020-00217
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    March 9, 2020
    Report Date
    April 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802140
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 MARCH 2020: LOT 132368: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2013. EXPIRATION DATE: 2018-06-30. 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 SINCE 2016. CLINICAL EVALUATION: MOBILIZATION OF THE FEMORAL STEM AFTER 7 YEARS IN CEMENTLESS PRIMARY THA, ACCORDING TO REPORT SUBSEQUENT TO A TRAUMATIC EVENT. THE STEM LOOKS RADIOGRAPHICALLY LOOSE AND UPSIZING WAS MANDATORY. NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. PRELIMINARY INVESTIGATION: PRELIMINARY VISUAL HIGHLIGHT SIGNS OF PROXIMAL OSTEOINTEGRATION, BUT THERE IS NO IMAGE DETAIL ON THE DISTAL PART. IMPLANTS COVERED IN BIOLOGICAL FLUIDS. LINER WITH SIGNS OF EXTRACTION. VISUAL INSPECTION: FEMORAL STEM WITH RESIDUAL OF HA LAYER ON THE VERY PROXIMAL PART, FEMORAL HEAD AND NECK WITH SCRATCHES DUE TO EXTRACTION. BURNISHING ON PE ARTICULATING SURFACE AND LIPIDIC ABSORPTION COLOURATION.

    Description of Event or Problem · 1

    ASEPTIC LOOSENING OF A QUADRA 6 YEARS AND 4 MONTHS AFTER PRIMARY. PATIENT REPORTED A FALL IN 2019. QUADRA STEM REVISED SUCCESSFULLY WITH A BIGGER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396089 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.032 132368 07630030802140

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention