BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BROACH

    MDR report key: 6110319 · Received November 17, 2016

    Report

    Report Number
    1818910-2016-31691
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    May 4, 2009
    Report Date
    October 25, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HTQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT EXPERIENCED A SMALL CALCAR CRACK WHILE BROACHING. BASED OFF THE OPERATIVE NOTE IT DOESN'T APPEAR THAT THE CRACK WAS CABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761665 UNKNOWN DEPUY BROACH HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention