BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL IMPACTOR

    MDR report key: 15045167 · Received July 18, 2022

    Report

    Report Number
    1818910-2022-13321
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    April 29, 2022
    Report Date
    July 18, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWA
    UDI-DI
    10603295130222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # PC-(B)(4). (B)(6) 2022 DEVICE WAS RECEIVED AT JRZ'S PAL ON (B)(6) 2022 IP-01425418. INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. THE PHOTO INVESTIGATION AND VISUAL EXAMINATION FOUND THE DEVICE CRACKED AND BROKEN. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ATTUNE IMPACTOR HAS A LARGE FRACTURE THROUGH ITS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057309 ATTUNE FEMORAL IMPACTOR ATTUNE INSTRUMENTS : IMPACTORS HWA DEPUY IRELAND - 9616671 2544-01-006 AU7478293 10603295130222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown