BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATUNE CRS FB TIB BASE SZ 6 CEM

    MDR report key: 13000386 · Received December 14, 2021

    Report

    Report Number
    1818910-2021-27837
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    April 21, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042808
    PMA / PMN Number
    K160700
    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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE PRODUCT CODE- 150640006 & LOT# 8770552: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 05-APR-2018. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: THERE ARE ZERO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. 4) EXPIRY DATE: 30-MAR-2028. 5) IFU REFERENCE: IFU-0902-00-873.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR LOW GRADE INFECT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS PROBABLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL BASE PLATE, TIBIAL STEM, TIBIAL INSERT, AND FEMUR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901677 ATUNE CRS FB TIB BASE SZ 6 CEM ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-40-006 8770552 10603295042808

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention ATTUNE CEMENTED STEM 14X80MM| ATTUNE PS FB INSRT SZ 6 5MM| ATTUNE PS FEM RT SZ 6 CEM| ATUNE CRS FB TIB BASE SZ 6 CEM| SMARTSET GHV GENTAMICIN 20G| SMARTSET GHV GENTAMICIN 40G