BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

    MDR report key: 8734043 · Received June 26, 2019

    Report

    Report Number
    3005180920-2019-00525
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 26, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802058
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JUNE 2019: LOT 162563: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JULY 2016. EXPIRATION DATE: 2021-06-29. 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 2 YEARS AND 1 MONTH DUE TO STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527813 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4 UNCEMENTED HIP STEM JDI MEDACTA INTERNATIONAL SA 162563 07630030802058

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention