BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 4013498 · Received August 15, 2014

    Report

    Report Number
    1818910-2014-25781
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT THE LOCKING CATCH HAD CRACKED AS REPORTED. 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. THE PRODUCT CONCERNED IN THIS COMPLAINT 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.

    Description of Event or Problem · 1

    THERE IS A BEIGE CLIP ON THE TOP OF THE INSTRUMENT WHICH WAS CHIPPED AND IT DIDN'T ALLOW THE LOCKING MECHANISM TO FUNCTION PROPERLY. IT IS STILL USABLE BUT DOES NOT LOCK PROPERLY. SURGEON CONTINUED USING THE INSTRUMENT WITHOUT ANY ISSUE. NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489362 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL LXH DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1