BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR RP INSRT SZ 9 16MM

    MDR report key: 20085891 · Received August 28, 2024

    Report

    Report Number
    1818910-2024-18223
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 28, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295048299
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDED: B5. CORRECTED: D6A. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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 #151630916 /LOT #4141432 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 # 151630916 /LOT #4141432 COMBINATION. 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 UPDATE WAS REVIEWED: TREATMENT/INTERVENTION: REMOVAL OF DEPUY COMPONENTS.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6) STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR SPIN OUT. INFORMATION RELATED TO SEVERITY OF EVENT IS NOT PROVIDED. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024 DATE OF EVENT: 03 JUN 2024 (RIGHT KNEE) TREATMENT: AWAITING FURTHER EVALUATION DEPUY PRODUCTS USED (NO REVISION COMPLETED): ADDITIONAL EVENT INFORMATION REVISION DATE: (B)(6) 2024 NEW INFORMATION WAS RECEIVED THAT INDICATES THE PATIENT HAS NOW UNDERGONE A REVISION FOR THE INSTABILITY AND SPIN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480182 ATTUNE CR RP INSRT SZ 9 16MM ATTUNE IMPLANT : KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 4141432 10603295048299

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention ATTUNE CR FEM RT SZ 9 CEM.| ATTUNE MEDIAL DOME PAT 41MM.| ATTUNE RP TIB BASE SZ 9 CEM.| DEPUY CMW 1 40G.| DEPUY CMW 1 40G.