BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14336935 · Received May 9, 2022

    Report

    Report Number
    3005180920-2022-00349
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 9, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802720
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 APRIL 2022. LOT 122653: 27 ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2012. EXPIRATION DATE: 2017-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER 5 YEARS AND 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243264 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK HIP STEM CEMENTLESS JDI MEDACTA INTERNATIONAL SA 01.12.32SN 122653 07630030802720

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention