BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTO CHANA DUAL OFFSET RMR HDL

    MDR report key: 14843746 · Received June 28, 2022

    Report

    Report Number
    1818910-2022-11914
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    April 12, 2022
    Report Date
    June 28, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6), (B)(6) 2022. UPDATE (B)(4) DECONTAMINATION STATUS. THE DEVICE WAS RECEIVED AT PAL JRZ. (B)(6) 2022. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS OF THE RETURNED SAMPLE (B)(6) /MTO CHANA DUAL OFFSET RMR HDL EXHIBITED THAT REAMER'S TIP PRESENTED AN OVERALL WORN APPEARANCE. A FUNCTIONAL TEST WAS PERFORMED (25500100). NO LOOSENING ON THE ASSEMBLY WAS OBSERVED DURING MATING OPERATION. 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. A-7507280 - JUN 21 2022; UPDATE (B)(4), (B)(4), DECONTAMINATION STATUS. THE DEVICE WAS RECEIVED AT PAL JRZ. 20/JUNE/2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE OFFSET REAMER HANDLE THAT CONNECTS TO THE HUDSON ADAPTER IS WORN AND WABBLES WHEN IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017808 MTO CHANA DUAL OFFSET RMR HDL HIP INSTRUMENTS : HANDLES HTO DEPUY ORTHOPAEDICS INC US PC2472978

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female