BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CR FB INSRT SZ 6 5MM

    MDR report key: 20438613 · Received October 14, 2024

    Report

    Report Number
    1818910-2024-21483
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    April 17, 2024
    Report Date
    October 14, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295045762
    PMA / PMN Number
    K101433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿IT WAS REPORTED THAT ON APR. 17, 2024, THE COLOR OF THE SIZE INDICATOR ON THE PACKAGE OF THE PRODUCT IN QUESTION DIFFERED FROM THE STANDARD PRODUCT VERSION. (STANDARD PRODUCT: YELLOW, SAID PRODUCT: PINK). NO FURTHER INFORMATION IS AVAILABLE¿. THE PRODUCT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE ATTUNE CR FB INSRT SZ 6 5MM REVEALED THAT THE OUTER PACKAGE LABEL HAS THE INCORRECT COLOR SIZE INDICATOR. THE PACKAGE WAS RETURNED INTACT WITH THE SHRINK-WRAP PLASTIC WITH NO SIGNS OF OPENING ATTEMPTS. THE OBSERVED ISSUE OF THE SIZE INDICATOR HAS BEEN ADDRESSED THROUGH DEPUY SYNTHES QUALITY SYSTEM. A DIMENSIONAL INSPECTION AND FUNCTIONAL TESTING WERE NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE COLOR INDICATOR OF THE ATTUNE CR FB INSRT SZ 6 5MM WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH DEPUY SYNTHES QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 151620605 LOT NUMBER: M5282N. ONE NR FOUND. NR-0220847 RELATED TO OUTER CARTON LABEL IDENTIFIED AS HAVING THE INCORRECT SIZE INDICATOR COLOR. LOT M5282N BOUNDED TO NR AND DISPOSITION WILL BE DOCUMENTED UNDER (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 ON APR. 17, 2024, THE COLOR OF THE SIZE INDICATOR ON THE PACKAGE OF THE PRODUCT IN QUESTION DIFFERED FROM THE STANDARD PRODUCT VERSION. (STANDARD PRODUCT: YELLOW, SAID PRODUCT: PINK). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231036 ATTUNE CR FB INSRT SZ 6 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671 M5282N 10603295045762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown