BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMA MI CALCAR REAMER SMALL

    MDR report key: 7694924 · Received July 17, 2018

    Report

    Report Number
    1818910-2018-64602
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 21, 2018
    Report Date
    June 21, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HTO
    UDI-DI
    10603295223627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (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 · 1

    (B)(4). EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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.

    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

    PLEASE SEE PHOTO OF THE NEW SHIELDED CALCAR PLANERS FROM THE CORAIL INSTRUMENTS. THE INTERNAL SLEEVE IN THE REAMER HEAD HAS FALLEN OUT, SO IT IS NOW TO LOOSE TO FIT OVER THE NECK SPIGOT FOR THE TRIAL NECK. WE WERE UNABLE TO USE IT DURING THE CASE WITH CE; I HAVE THIS ITEM TO RETURN FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538687 PROXIMA MI CALCAR REAMER SMALL HIP INSTRUMENTS : REAMERS HTO DEPUY ORTHOPAEDICS, INC. 1818910 AB3732169 10603295223627

    Patients

    Seq Age Sex Outcome Treatment
    1