BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 3772297 · Received March 19, 2014

    Report

    Report Number
    9613350-2014-03379
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    February 24, 2014
    Report Date
    January 18, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    Z-2415/2426-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON FEBRUARY 08, 2016 TO ENTER ADDITIONAL INFORMATION WHICH HAD BEEN RECEIVED ON JANUARY 18, 2016. THE CAUSE FOR THIS COMPLAINT HAS NOT BEEN REPORTED, BUT SINCE THE DATE OF THE IMPLANTATION HAS NOT BEEN PROVIDED, THIS CASE WILL BE TREATED AS A COMPLAINT THAT MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION IN JULY 2008 AS NOTIFICATION (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT HAS NOT BEEN REVISED AND IS CURRENTLY BEING MONITORED. THE CAUSE FOR THIS COMPLAINT HAS NOT BEEN REPORTED, BUT SINCE THE DATE OF THE IMPLANTATION HAS NOT BEEN PROVIDED, THIS CASE WILL BE TREATED AS A COMPLAINT THAT MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION IN JULY 2008 AS NOTIFICATION (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON UNKNOWN DATE. CURRENTLY, THE PT IS BEING MONITORED DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON AN UNKNOWN SIDE(EXACT DATE NOT REPORTED) . THE PATIENT WAS REVISED ON UNKNOWN DATE DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165014 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R