BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM RASP TRIAL CO/FJD T11

    MDR report key: 7706108 · Received July 20, 2018

    Report

    Report Number
    1818910-2018-64871
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Report Date
    June 26, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    EKD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED. PRODUCT COMPLAINT # : (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIZE 11 FEMORAL BROACH WAS USED AND IT WAS FLUSH, BUT WHEN PUT THE SIZE 11 IMPLANT WAS PROUD BY 5MM. MISMATCHED BETWEEN THE BROACH AND THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547782 FEM RASP TRIAL CO/FJD T11 MISCELLANEOUS JOINT INSTRUMENTS : CUTTING INSTRUMENTS EKD DEPUY FRANCE SAS - 3003895575 1358920

    Patients

    Seq Age Sex Outcome Treatment
    1