BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATUNE REV RP TIB BASE SZ 6 CEM

    MDR report key: 8101371 · Received November 26, 2018

    Report

    Report Number
    1818910-2018-76249
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    October 31, 2018
    Report Date
    October 31, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042907
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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) THIS IS A DUPLICATE REPORT OF RA-(B)(4). RA-(B)(4) IS BEING RETRACTED AS IT IS REPORT DUPLICATION. RA-(B)(4) WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942418 ATUNE REV RP TIB BASE SZ 6 CEM KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 8768960 10603295042907

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention