BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 5

    MDR report key: 9738112 · Received February 21, 2020

    Report

    Report Number
    3005180920-2020-00075
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802065
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03-FEB-2020: LOT 162977: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2016. EXPIRATION DATE: 2021-07-21. 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 MEDACTA MEDICAL AFFAIRS DIRECTOR: HIP REVISION SURGERY PERFORMED 1 YEAR AND 10 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEARS OLD MAN DUE TO FAILURE OF SECONDARY FIXATION. REPORTEDLY, OSSEOINTEGRATION NEVER TOOK PLACE. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS, ACTIVITY LEVEL AND COMORBIDITIES IS AVAILABLE. THE PARTIAL IMAGE PROVIDED DOES NOT ALLOW A PROPER CLINICAL EVALUATION. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO PAIN AND NOT OSSEOINTEGRATION OF THE STEM AFTER ABOUT 2 YEARS FROM THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201623 STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 5 HIP UNCEMENTED STEM JDI MEDACTA INTERNATIONAL SA 01.12.025 162977 07630030802065

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention