BEUDAMED
    FDA Adverse Event Other Summary report: N

    FITMORE HIP STEM

    MDR report key: 3202055 · Received June 26, 2013

    Report

    Report Number
    9613350-2013-01667
    Event Type
    Other
    Date Received
    June 26, 2013
    Date of Event
    July 18, 2011
    Report Date
    June 14, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 TO DATE. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, AS THE PT HAS NOT BEEN REVISED. SHOULD ADD'L INFO BE RECEIVED, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER REFERENCE #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 2 YEAR F/U CHECK, THE PT COMPLAINED OF MODERATE PAIN IN THE LATERAL AND MEDICAL THIGH AT REST. AT 3-YEAR F/U ONLY 'MILD PAIN' IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290571 FITMORE HIP STEM FITMORE HIP STEM A, SIZE 3 KWA ZIMMER GMBH 2472188

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR