BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 3772121 · Received April 7, 2014

    Report

    Report Number
    9613350-2014-03423
    Event Type
    Other
    Date Received
    April 7, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT HAD 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 Z-2415/2426/2008. SHOULD ADD'L INFO BECOME AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (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 UNK DATE AND PT IS BEING MONITORED DUE TO UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208998 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other