BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATUNE REV RP TIB BASE SZ 4 CEM

    MDR report key: 16311536 · Received February 7, 2023

    Report

    Report Number
    1818910-2023-03053
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    December 4, 2022
    Report Date
    February 7, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042884
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: BFARM DHR REVIEW REQUEST. PRODUCT DESCRIPTION: ATUNE REV RP TIB BASE SZ 4 CEM. PRODUCT CODE: 150660004. LOT NUMBER: 9876932. PLEASE PROVIDE: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 17/09/2021. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO. 4) EXPIRY DATE: 21/08/2031. 5) IFU REFERENCE: (B)(4). H10 ADDITIONAL NARRATIVE: ADDED: D4 - EXPIRATION DATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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. 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 · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR ANEMIA. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: POST OP TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137311 ATUNE REV RP TIB BASE SZ 4 CEM KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-60-004 9876932 10603295042884

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention ATTUNE MEDIAL ANAT PAT 38MM| ATTUNE PS FEM RT SZ 5 CEM| ATTUNE PS RP INSRT SZ5 5MM| ATUN TIB SLV M/L 37MM HALF POR| ATUNE REV RP TIB BASE SZ 4 CEM| SMARTSET GHV GENTAMICIN 20G| SMARTSET GHV GENTAMICIN 40G