BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 5 CEM

    MDR report key: 9202243 · Received October 17, 2019

    Report

    Report Number
    1818910-2019-110351
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 23, 2019
    Report Date
    September 24, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042396
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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, 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

    PLEASE SEE INFORMATION REFERENCE A REVISION OF ATTUNE TIBIAL COMPONENT AND POLY INSERT. REVISION OP DATE: (B)(6) 2019. REASON FOR REVISION: CONSTRUCT I.E FB PS. LOOSE TIBIAL COMPONENT. COMPONENT CODES REMOVED TIBIAL TRAY 1506-00-005, LOT NO. 8469463; POLY INSERT 1516-40-605, LOT NO. H18277.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994867 ATTUNE FB TIB BASE SZ 5 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 8469463 10603295042396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention