BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROACH CORAIL AMT 11

    MDR report key: 786094 · Received November 16, 2006

    Report

    Report Number
    1818910-2006-03672
    Event Type
    Injury
    Date Received
    November 16, 2006
    Date of Event
    October 17, 2006
    Report Date
    October 17, 2006
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    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.

    Description of Event or Problem · 1

    THE SIZE 11 CORAIL STEM SAT 2 CM PROUD AFTER SIZE 11 BROACHING. THE SURGEON REBROACHED WITH SIZE 11 STEM, WHICH SAT FLUSH. A SIZE 12 BROACH THEN SAT 2 CM PROUD AS DID THE SIZE 11 IMPLANT. THE SURGEON CHOSE TO CEMENT A SUMMIT STEM. THIS CAUSED A LENGTHY SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROACH CORAIL AMT 11 MANUAL INSTRUMENT LXH DEPUY FRANCE S.A. NA 1997487

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention