BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR VAR NECK SEGMENT COR AMT

    MDR report key: 11057030 · Received December 22, 2020

    Report

    Report Number
    1818910-2020-27516
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    December 8, 2020
    Report Date
    December 8, 2020
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LXH
    UDI-DI
    10603295258223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KLA NECK SEGMENT WOULD NOT FULLY SEAT. NO ADDITIONAL INFORMATION AVAILABLE. NO SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518765 COR VAR NECK SEGMENT COR AMT HIP INSTRUMENTS : FEMORAL TRIALS LXH DEPUY IRELAND 9616671 L20432 10603295258223

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR