BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 3913994 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22672
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUS INVESTIGATIONS HAVE FOUND THAT DESIGN CHANGE WAS IMPLEMENTED FOR THIS PRODUCT (ECO-321614) TO PREVENT THE ANTI-ROTATION PIN FROM LOADING THE PLASTIC HANDLE TO MINIMISE FURTHER FAILURES OF THE HANDLE CRACKING. DRA-001725 WAS CREATED TO INVESTIGATE THE USE OF RADEL IN INSTRUMENTS AND CONCLUDED THAT THE DATA SHOWED NO SYSTEMATIC FAILURES OF EXTRUDED RADEL FOR USE IN INSTRUMENTS. FOLLOWING THE DRA A HHE WAS COMPLETED (DVA-108291-HHE) AND CONCLUDED THAT THE RISK IS MEDIUM AND THAT NO FURTHER ACTION IS NECESSARY. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF HANDLE BREAKAGE. THE INITIAL REPORT STATED ALL PIECES WERE RETRIEVED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    CURVED CUP IMPACTOR HANDLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391710 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 P14832001

    Patients

    Seq Age Sex Outcome Treatment
    1