BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5

    MDR report key: 10147233 · Received June 12, 2020

    Report

    Report Number
    3005180920-2020-00326
    Event Type
    Injury
    Date Received
    June 12, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802065
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 19 MAY 2020: LOT 1900008: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2019. EXPIRATION DATE: 14.04.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT DISLOCATED IN THE HOSPITAL AND AFTER FURTHER INVESTIGATION WITH X-RAY IT WAS DISCOVERED SUBSIDENCE OF THE FEMORAL COMPONENT, THE SURGEON SUSPECTS THAT DURING THE PRIMARY SURGERY 8 DAYS BEFORE OCCURRED A BONE FRACTURE, BUT IT IS NOT CONFIRMED IF THE FRACTURE OCCURRED DURING OF AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM AND HEAD AND CABLED THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614853 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5 CEMENTLESS, HA COATED STD STEM JDI MEDACTA INTERNATIONAL SA 01.12.025 1900008 07630030802065

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention