BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ANKLE TIBIAL INSERT

    MDR report key: 10791759 · Received November 5, 2020

    Report

    Report Number
    1818910-2020-23980
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    October 19, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. (B)(4).

    Description of Event or Problem · 1

    PATIENT NEEDS TO REVISE (REPLACE) THE BEARING ON A NOW DISCONTINUED MOBILITY ANKLE REPLACEMENT. POLYETHYLENE SPACER APPEARS TO HAVE BROKEN WITHIN THE ANKLE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254844 UNKNOWN ANKLE TIBIAL INSERT ANKLE TIBIAL INSERT KXC DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention