BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLS BREVIUS HIP STEM GENERIC

    MDR report key: 3243121 · Received July 19, 2013

    Report

    Report Number
    9613350-2013-01754
    Event Type
    Other
    Date Received
    July 19, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 HAS NOT BEEN REVISED BUT IS CURRENTLY BEING MONITORED DUE TO PAIN IN THE THIGH. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, AS THE PT HAS NOT BEEN REVISED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH A CLS BREVIUS HIP STEM GENERIC (DATE NOT PROVIDED) AND IS CURRENTLY BEING MONITORED DUE TO PAIN IN THE THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338142 CLS BREVIUS HIP STEM GENERIC CLS BREVIUS HIP STEM GENERIC KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other