BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CORAIL BROACH

    MDR report key: 2983189 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-12951
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPATED:THE BROACH HAVING BEEN USED DURING THIS EVENT WAS NOT RETURNED OR IDENTIFIED. A PRODUCT AND LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    CORAIL STEM DID NOT SEAT TO THE SAME LEVEL AS BROACH. SURGEON DECIDED TO BACK OUT THE STEM, BUT IT WOULD NOT COME OUT. HE HAD TO PERFORM AN OSTEOTOMY TO GET THE STEM OUT OF THE FEMUR. THIS RESULTED IN A SURGICAL DELAY OF 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87664 UNKNOWN DEPUY CORAIL BROACH HIP INSTRUMENT LXH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention