BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7

    MDR report key: 8731006 · Received June 25, 2019

    Report

    Report Number
    3005180920-2019-00511
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802089
    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 162216: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MAY 2016. EXPIRATION DATE: 2021-05-09. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND 8 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP, FOR A STEM LOOSENING. STEM, HEAD AND LINER REVISED SUCCESSFULLY. THE PATIENT PRESENTED ALSO A STEM LENGTH DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524776 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 162216 07630030802089

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention