BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE REV T AUGTRL 15MM SZ5LL

    MDR report key: 8861930 · Received August 5, 2019

    Report

    Report Number
    1818910-2019-100101
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LXH
    UDI-DI
    10603295437154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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 ==> NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. 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

    PRODUCT COMPLAINT # (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

    INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653340 ATTUNE REV T AUGTRL 15MM SZ5LL FEMORAL TRIALS LXH DEPUY IRELAND 9616671 SO2035364 10603295437154

    Patients

    Seq Age Sex Outcome Treatment
    1