BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PS FEM RT SZ 5 NAR CEM

    MDR report key: 13553178 · Received February 17, 2022

    Report

    Report Number
    1818910-2022-03055
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    February 7, 2022
    Report Date
    February 17, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295041849
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. EXAMINATION OF THE PROVIDED PHOTOGRAPHIC EVIDENCE DENOTED THAT THE INNER BLISTER OF THE PACKAGING WAS MELTED/DEFORMED. THE PACKAGE WAS ALREADY OPENED . DUE TO THE DEFORMATION OF THE BLISTER, IT IS NOT UNREASONABLE TO DETERMINE THAT IT WAS DIFFICULT TO UNIFORMLY REMOVE THE TYVEK LID FROM THE BLISTER. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (150410225/9850926) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    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. H10 ADDITIONAL NARRATIVE: 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

    INNER PACKAGING WAS DIFFICULT TO REMOVE FROM THE OUTER PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3923 ATTUNE PS FEM RT SZ 5 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL NJL DEPUY IRELAND - 9616671 1504-10-225 9850926 10603295041849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown