BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN DIST. CURVED 18/200

    MDR report key: 4013014 · Received August 11, 2014

    Report

    Report Number
    9613350-2014-03775
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PT HAS NOT BEEN REVISED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PT WAS IMPLANTED WITH A REVITAN STEM ON (B)(6) 2009. THEN, ON UNK DATE, THE STEM BROKE. A REVISION SURGERY IS PLANNED (DATE UNK, NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476249 REVITAN DIST. CURVED 18/200 REVITAN DIST. CURVED 18/200 KWA ZIMMER GMBH NA 2481898

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other