BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS UNKNOWN

    MDR report key: 2504773 · Received March 23, 2012

    Report

    Report Number
    9613350-2012-00360
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 7, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADD'L INFO BECOME AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT WAS REVISED FOR UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS UNKNOWN NONE NQP ZIMMER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R