BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR RP INSRT SZ 6 5MM

    MDR report key: 7882595 · Received September 17, 2018

    Report

    Report Number
    1818910-2018-69583
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 20, 2018
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JWH
    UDI-DI
    10603295047865
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT MEDICAL PRODUCTS: ATTUNE RP TIB BASE SZ 5 CEM KNEE TIBIAL TRAY COMPONENT; ATTUNE CR FEM RT SZ 6 NAR CEM KNEE FEMUR COMPONENT; ATTUNE CR RP INSRT SZ 6 5MM KNEE TIBIAL INSERT COMPONENT; UNKNOWN KNEE PATELLA COMPONENT; UNKNOWN BONE CEMENT.

    Additional Manufacturer Narrative · 1

    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 WILL 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.

    Description of Event or Problem · 1

    ATTUNE KNEE REVISION; DR. (B)(6), (B)(6) 2018. IMPLANTS REVISED DUE TO REPORTED PAIN. DURING THE CASE IT WAS NOTED THAT THE IMPLANTS WERE WELL FIXED AND NO LOOSENING WAS APPARENT. REVISION COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723594 ATTUNE CR RP INSRT SZ 6 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT JWH DEPUY IRELAND 9616671 8476694 10603295047865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention