BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 4871208 · Received June 26, 2015

    Report

    Report Number
    1818910-2015-24490
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TERRITORY 238 REPORTS THE IMPACTOR WAS BROKEN DURING SURGERY. PLASTIC ANTI-ROTATION CLIP BROKE. CONCLUSION AND JUSTIFICATION STATUS: THE INVESTIGATION COULD NOT CONFIRM THE FAILURE OF THE DEVICE AS NO DEVICE WAS RETURNED. PREVIOUSLY A CORRECTIVE ACTION WAS IDENTIFIED FOR THIS FAILURE MODE WHEREBY A DESIGN CHANGE WAS IMPLEMENTED AND ROUTED ON ECO-193427 (DWG-106984) 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 TO THE REVISED DESIGN HOWEVER NO FURTHER ACTIONS ARE IDENTIFIED AT THIS CURRENT TIME AS THE ROOT CAUSE OF THE COMPLAINT IS ATTRIBUTED TO USER ERROR. 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

    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. (B)(4).

    Description of Event or Problem · 1

    IMPACTOR WAS BROKEN DURING SURGERY. PLASTIC ANTI-ROTATION CLIP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415371 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. PC34377001

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR