BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1, SHORT NECK

    MDR report key: 13768694 · Received March 15, 2022

    Report

    Report Number
    3005180920-2022-00171
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 3, 2022
    Report Date
    March 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802713
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2022: LOT 082700: 25 ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2008. EXPIRATION DATE: 2013-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018.

    Description of Event or Problem · 0

    AT 13 YEARS 1 MONTH AFTER THE PRIMARY, 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 AND HEAD WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29108 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1, SHORT NECK CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.31SN 082700 07630030802713