BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM 4 STD

    MDR report key: 6282452 · Received January 27, 2017

    Report

    Report Number
    3005180920-2017-00006
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    December 29, 2016
    Report Date
    January 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: POSTOPERATIVE FEMORAL FRACTURE OCCURRED 11 DAYS AFTER PRIMARY CEMENTLESS THA IN A (B)(6) MAN. THE FRACTURE MAY BE DUE TO A TRAUMATIC EVENT HAPPENED DURING REHABILITATION, PROBABLY A TORSIONAL STRESS CONSEQUENT TO A SUDDEN MOVEMENT. THERE IS NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 25 JANUARY 2017. LOT 151856: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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 SAID THAT THE BONE HIP BROKE AND THEN HE FELL DOWN. IT IS NOT CLEAR IF HE TWISTED OR TRIPPED PRIOR TO THE FRACTURE, CAUSING HIM TO FALL OVER. STEM, HEAD AND LINER WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65974 QUADRA-H CEMENTLESS, HA COATED STEM 4 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 151856

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention