BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE RP PS ARTIC SURF SZ3

    MDR report key: 8420123 · Received March 14, 2019

    Report

    Report Number
    1818910-2019-87247
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 26, 2019
    Report Date
    February 26, 2019
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JWH
    UDI-DI
    10603295132837
    PMA / PMN Number
    K140881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. ADDED: CONCOMITANT MEDICAL PRODUCTS. CORRECTED: DEVICE EVALUATED BY MFR. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. 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

    IT WAS REPORTED THAT THE ATTUNE 5Z 3 RP ARTIC SURF WAS BROKE INTO TWO PIECES WHEN IMPACTING IN FOR TRIALING. BOTH PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214637 ATTUNE RP PS ARTIC SURF SZ3 ATTUNE INSTRUMENTS : TIBIAL TRIALS JWH DEPUY IRELAND 9616671 MVMBRB740 10603295132837

    Patients

    Seq Age Sex Outcome Treatment
    1