BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/C & MOD CATH TRL 45/28

    MDR report key: 11130962 · Received January 7, 2021

    Report

    Report Number
    1818910-2021-00571
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 18, 2020
    Report Date
    December 18, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295084624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 BOTTOM OF 45 UNIPOLAR/BIPOLAR BLACK OUTER BALL TRIAL WAS DAMAGED AND ANOTHER MODULAR ENDO HEADS TRIALS AND INSTRUMENT TRAY WAS USED. SCRUB TECH THREW AWAY TRIAL AFTER CASE SO IT CANNOT BE SENT BACK. IT DIDN¿T DISRUPT THE CASE OR SET BACK THE CASE TIME. IT WAS CAUGHT IN TIME FOR THE OTHER TRAY TO BE BROUGHT TO THE ROOM TO BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27429 S/C & MOD CATH TRL 45/28 HIP INSTRUMENTS : ACETABULAR TRIALS LXH DEPUY ORTHOPAEDICS INC US 2055-45-000 10603295084624

    Patients

    Seq Age Sex Outcome Treatment
    1