BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE MEDIAL DOME PAT 41MM

    MDR report key: 7966898 · Received October 15, 2018

    Report

    Report Number
    1818910-2018-72565
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    June 18, 2018
    Report Date
    October 11, 2018
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JWH
    UDI-DI
    10603295056706
    PMA / PMN Number
    K103756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: EVALUATION OF THE RETURNED DEVICE AND PACKAGING COMPONENTS CONFIRMS THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: PRODUCT CODE 151820041, LOT NUMBER 8695690. DEVICE HISTORY REVIEW: DHR REVIEW PRODUCT CODE 151820041, WORK ORDER (B)(4) WAS MANUFACTURED ON 07 JAN 2018. 35 PARTS OF ATTUNE MEDIALIZED DOMES (41MM) WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. 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 WHEN THEY OPENED THE PACKAGE AND THE PAPER TORE IMPROPERLY, COMPROMISED STERILITY OF IMPLANT PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805714 ATTUNE MEDIAL DOME PAT 41MM ATTUNE IMPLANT : KNEE PATELLA JWH DEPUY IRELAND 9616671 8695690 10603295056706

    Patients

    Seq Age Sex Outcome Treatment
    1