BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 4324921 · Received December 12, 2014

    Report

    Report Number
    1818910-2014-34124
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 18, 2014
    Report Date
    November 18, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT THE LOCKING CATCH OF THE ANGLED ACET INSERTER HAD FRACTURED. THE COMPLAINT STATES THAT THE INSTRUMENT´S GREY PLASTIC TO LOCK THE CARDAN JOINT PART OF THE INSTRUMENT IS BROKEN. PREVIOUSLY A CORRECTIVE ACTION WAS IDENTIFIED FOR THIS FAILURE MODE WHEREBY A DESIGN CHANGE WAS IMPLEMENTED AND ROUTED ON ECO-193427 (B)(4) IN 2007 IN ORDER TO STRENGTHEN THE LOCKING CATCH. THE DESIGN VERIFICATION WAS COMPLETED AND ROUTED ON DVA-101743-FDE AND CONCLUDED THAT THERE ARE NO OUTSTANDING ACTIONS IDENTIFIED. THIS PRODUCT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF ECO-193427. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE INSTRUMENT´S GREY PLASTIC TO LOCK THE CARDAN JOINT PART OF THE INSTRUMENT IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810301 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 PC30385001

    Patients

    Seq Age Sex Outcome Treatment
    1