BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATUNE REV RP TIB BASE SZ 7 CEM

    MDR report key: 17773569 · Received September 19, 2023

    Report

    Report Number
    1818910-2023-19060
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    January 1, 2023
    Report Date
    September 19, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042914
    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. PRODUCT DESCRIPTION: ATUNE REV RP TIB BASE SZ 7 CEM. PRODUCT CODE: 150660007. LOT NUMBER: 9033554 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 19-FEB-2019. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. 4) EXPIRY DATE: 31-JAN-2029. 5) IFU REFERENCE: 090200876. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PRODUCT DESCRIPTION: ATUNE REV RP TIB BASE SZ 7 CEM. PRODUCT CODE: 150660007. LOT NUMBER: 9033554. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 19-FEB-2019. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. 4) EXPIRY DATE: 31-JAN-2029. 5) IFU REFERENCE: 090200876.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4-EXPIRATION DATE OF THE DEVICE WAS NOT PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR SLIGHT GAIT INSTABILITY LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019 DATE OF EVENT: UNKNOWN IN 2023 (LEFT KNEE). TREATMENT: RECOMMENDATION FOR KNEE CONTROL IN THE ORTHOPEDIC DEPARTMENT. DEPUY PRODUCTS USED (NO REVISION COMPLETED)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997972 ATUNE REV RP TIB BASE SZ 7 CEM KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 9033554 10603295042914

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention ATTUNE MEDIAL DOME PAT 41MM.| ATTUNE PS FEM LT SZ 8 CEM.| ATTUNE PS RP INSRT SZ8 6MM.| ATUN TIB SLV M/L 45MM HALF POR.| ATUNE PRESSFIT STR STEM14X60MM.| COMPETITOR PRODUCT (BIOMET CEMENT).