BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CRS RP INSRT SZ 8 10MM

    MDR report key: 18969652 · Received March 25, 2024

    Report

    Report Number
    1818910-2024-06508
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    March 14, 2024
    Report Date
    March 25, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295056256
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 151710810, LOT - 4110003 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED 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 : A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 151710810, LOT - 4110003 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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

    ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? NO. C. WAS THERE AN INFECTION RELATED TO IRRIGATION AND DEBRIDEMENT PROCEDURE? UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND UPSIZED POLY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722 ATTUNE CRS RP INSRT SZ 8 10MM KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 4110003 10603295056256

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention