BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL IMPACTOR

    MDR report key: 13558414 · Received February 18, 2022

    Report

    Report Number
    1818910-2022-03073
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 18, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWA
    UDI-DI
    10603295130222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY ==> THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. A BROKEN CONDITION WAS FOUND. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY. THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. A BROKEN CONDITION WAS FOUND. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 0

    DEVICES 3, 4, 5 AND 6: REPORTED TO BE PART OF COMPLAINT - (B)(4). COMPLAINT AGE - CLOSED ISSUES - 2 LOT CODE MISMATCHES, 2 EXTRA PRODUCTS PRODUCT CODES - (X2) 254401017 (1 EXTRA PRODUCT AND 1 LOT CODE MISMATCH), (X1) 254401006 (1 LOT CODE MISMATCH) AND (X1) 254401003 (1 EXTRA PRODUCT) LOT CODES - NW143589, NW143585, AU6984060 AND A4071020 RECEIVED AT CG LABS - ON (B)(6) 2021 WITH TRACKING NUMBER (B)(6). SHIPPED FROM CGL TO (B)(6) - ON (B)(6) 2021 WITH TRACKING NUMBER (B)(6), UNDER (B)(4). DECONTAMINATION RUN - 1182-777.

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530107 ATTUNE FEMORAL IMPACTOR ATTUNE INSTRUMENTS : IMPACTORS HWA DEPUY IRELAND - 9616671 2544-01-006 AU6984060 10603295130222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown