BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET TPRD HEX SCDR U-JOINT

    MDR report key: 3694078 · Received March 22, 2014

    Report

    Report Number
    1818910-2014-14998
    Event Type
    Malfunction
    Date Received
    March 22, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 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

    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

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE COMPLAINT. PREVIOUS AND ONGOING INVESTIGATION INTO THIS ISSUE BY THE SUPPLIER HAS DETERMINED THAT THE REPORTED DEVICE WAS MANUFACTURED FROM THE CORRECT MATERIAL AND TO THE REQUIRED SPECIFICATIONS. THE ROOT CAUSE IS ATTRIBUTED TO CORROSION, WITH CARBIDE EMBRITTLEMENT AS A POSSIBLE CONTRIBUTING FACTOR. HOWEVER, IMPROVEMENTS TO THE HEAT TREATING PROCESS HAVE BEEN RECOGNIZED AND A SUPPLIER CHANGE REQUEST TO HEAT TREAT ALL 400 SERIES STAINLESS STEEL COMPONENTS IN THE UNITED STATES HAS BEEN INITIATED. SCR-002557 WAS INITIATED AND IS CURRENTLY IN PROCESS. THE SUPPLIER CHANGE REQUESTS THE USE OF AN ALREADY APPROVED HEAT TREAT SUPPLIER, LAKE CITY HEAT TREAT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED BY THE REP THAT A CRACK WAS NOTICED IN THE SCREW DRIVER TIP. THE CRACK WAS IN THE SCREW DRIVER TIP ACROSS THE ROTATING PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170860 QUICKSET TPRD HEX SCDR U-JOINT HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 SO2005625

    Patients

    Seq Age Sex Outcome Treatment
    1