BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD, SHORT NECK

    MDR report key: 6134998 · Received November 30, 2016

    Report

    Report Number
    3005180920-2016-00622
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 NOVEMBER 2016. LOT 162567: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JUNE 2016. EXPIRATION DATE: 2021-06-13. 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 CAME IN COMPLAINING OF PAIN. THE SURGEON NOTICED THE PATIENT HAD A PERIPROSTHETIC FRACTURE. THE SURGEON REVISED THE STEM, HEAD AND SECURED WITH CABLES. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785160 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD, SHORT NECK CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 162567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention