BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET TPRD HEX SCDR U-JOINT

    MDR report key: 3897750 · Received June 26, 2014

    Report

    Report Number
    1818910-2014-22092
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF TIP BREAKAGE. PREVIOUS INVESTIGATIONS FOUND THE ROOT CAUSE IS ATTRIBUTED TO THE SUPPLIER¿S HEAT TREATING PROCESS; CORROSION FOUND WITH CARBIDE EMBRITTLEMENT AS A POSSIBLE CONTRIBUTING FACTOR. 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 IMPLEMENTED AND RELEASED. SCR-002557 RELEASED 10/03/2012 TO REQUEST THE USE OF AN ALREADY APPROVED HEAT TREAT SUPPLIER, (B)(4). MONITOR THROUGH TREND ANALYSIS. THE DATE CODE A0510 INDICATES THE INSTRUMENT WAS MANUFACTURED IN MAY 2010, AND WAS MANUFACTURED PRIOR TO THE CHANGES. NO FURTHER ACTION INDICATED.

    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.

    Description of Event or Problem · 1

    SCREW TIP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374386 QUICKSET TPRD HEX SCDR U-JOINT HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. AO510

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR