BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS TRIAL HUMERAL PE-INLAY 36-3

    MDR report key: 3960857 · Received June 27, 2014

    Report

    Report Number
    9613350-2014-03661
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID RECEIVE THE DEVICE FOR REVIEW AND THE INVESTIGATION IS ONGOING. THE DEVICE HISTORY RECORD WERE REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS ADDITIONAL INFO BECOMES AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED FROM (B)(6) AN INCIDENT USER REPORT. THE INCIDENT USER REPORT STATES THE FOLLOWING: "AT THE TIME OF THE TEST - REPOSITIONING STEP IT WAS OBSERVED AFTER REMOVAL OF THE TEST INLAY GREEN ABRASION CHIPS WITHIN THE HUMERUS SHELL. THE CHIPS WERE RETRIEVED COMPLETELY AND EASILY, THERE WAS NO HARM OR INJURY TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376161 AS TRIAL HUMERAL PE-INLAY 36-3 AS TRIAL HUMERAL PE-INLAY 36-3 KWA ZIMMER GMBH NA 12.803484

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR