BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LPS DSTL FEM TRL LO PROFILE RT

    MDR report key: 8235446 · Received January 10, 2019

    Report

    Report Number
    1818910-2019-80444
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 13, 2018
    Report Date
    December 13, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295157830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE DEVICES WERE REVIEWED BY DEPUY MELBOURNE AND CONFIRMED THE SPRING IS DAMAGED. ROOT CAUSE IS ATTRIBUTED TO WEAR. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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

    (B)(4). 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

    SPRING IS BENT AND TRIALS ARE NOT ABLE TO BE PUT TOGETHER PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31254 LPS DSTL FEM TRL LO PROFILE RT HIP INSTRUMENTS : FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS INC US AF0108 10603295157830

    Patients

    Seq Age Sex Outcome Treatment
    1