BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL HA W/O COLLAR S11 145MM

    MDR report key: 3946307 · Received July 21, 2014

    Report

    Report Number
    1818910-2014-23830
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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 PATIENT WAS REVISED BECAUSE THE PATIENT FELL APPARENTLY CAUSING STEM LOOSENING AND THE PERIPROSTHETIC FRACTURE. DOI: 2003 - DOR: (B)(6) 2014 (LEFT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PER THE INITIAL REPORTING; THERE IS NO ADDITIONAL INFORMATION AVAILABLE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. 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. 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

    THE PATIENT WAS REVISED BECAUSE THE PATIENT FELL APPARENTLY CAUSING STEM LOOSENING AND THE PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424927 CORAIL HA W/O COLLAR S11 145MM HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 1505739

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention