BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CRS RP INSRT SZ 6 6MM

    MDR report key: 18968774 · Received March 25, 2024

    Report

    Report Number
    1818910-2024-06488
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    March 13, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295056010
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND, NO NC¿S ASSOCIATED WITH THIS PRODUCT PART#: 151710606, LOT#: 4010083 COMBINATION. 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 SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND, NO NC¿S ASSOCIATED WITH THIS PRODUCT PART#: 151710606, LOT#:4010083 COMBINATION. ADDED: D4: (EXPIRATION DATE).

    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

    IT WAS REPORTED THAT THE PATIENT FELL AND DEHISCED HER WOUND, AND THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND POLY EXCHANGE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460947 ATTUNE CRS RP INSRT SZ 6 6MM KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 4010083 10603295056010

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention