BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACER IMPACTOR TIP

    MDR report key: 6732346 · Received July 21, 2017

    Report

    Report Number
    1818910-2017-21521
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    April 24, 2017
    Report Date
    June 23, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWA
    UDI-DI
    10603295116011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PREVIOUS MEDWATCHES IS LINKED TO COM-(B)(4) PRODUCT COMPLAINT # ==> PC-(B)(4) INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE COMPLAINT. 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 POLY TIPS OF THE IMPACTOR WAS WORN OUT. ON (B)(6) 2017 - EVALUATION OF THE RETURNED TIPS FOUND TWO LOTS WITH PIECES OF MATERIAL MISSING. LOTS 5236860 & 5091011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513153 SPACER IMPACTOR TIP SHOULDER INSTRUMENT/TRIAL HWA DEPUY ORTHOPAEDICS, INC. 1818910 5236860 10603295116011

    Patients

    Seq Age Sex Outcome Treatment
    1