BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6

    MDR report key: 11560724 · Received March 24, 2021

    Report

    Report Number
    3005180920-2021-00232
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802188
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23-MAR-2021. LOT 081861: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2008. EXPIRATION DATE: 2013-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    STEM LOOSENING 12 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. NO REVISION HAS BEEN PERFORMED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457008 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.036 081861 07630030802188

    Patients

    Seq Age Sex Outcome Treatment
    1 Other