BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIB BASE SZ 5 POR

    MDR report key: 19043188 · Received April 4, 2024

    Report

    Report Number
    1818910-2024-07087
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 25, 2024
    Report Date
    April 1, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    MBH
    UDI-DI
    10603295507420
    PMA / PMN Number
    K213781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 (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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : IT WAS REPORTED THAT ITEM OPENED (BOX READS SZ 5 AFFIXIUM 1506-21-005) STICKER INSIDE BOX READS SZ 6 (1506-21-006) LOT JA06A0954. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE LABEL CORRESPONDING TO SIZE 6 WAS MISTAKENLY PLACED ON THE PACKAGE OF THE ATTUNE FB TIB BASE SZ 5 POR. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE FB TIB BASE SZ 5 POR WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION. 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 SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. HOWEVER, A NR HAS BEEN INITIATED TO ADDRESS THE CURRENT COMPLAINT ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE ITEM WAS OPENED (BOX READS SZ 5 AFFIXIUM 1506-21-005) LOT??? THE STICKER INSIDE BOX READS SZ 6 (1506-21-006) LOT JA06A0954.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017647 ATTUNE FB TIB BASE SZ 5 POR KNEE IMPLANT - TIBIAL TRAY MBH DEPUY IRELAND - 3015516266 JA05A1115 10603295507420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown