BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIP STEM GENERIC

    MDR report key: 4173770 · Received October 9, 2014

    Report

    Report Number
    9613350-2014-03983
    Event Type
    Other
    Date Received
    October 9, 2014
    Date of Event
    June 1, 2013
    Report Date
    September 17, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICE, X-RAYS OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THE CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). CONTINUED - STILL IMPLANTED.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A HIP SYSTEM PRODUCT ON THE LEFT SIDE ON (B)(6) 2007. ON (B)(6) 2013 "FOLLOWING RADIOGRAPHIC TESTING FOR EPISODES OF PAIN IN LEFT HIP, AN ABNORMAL FRACTURE OF THE IMPLANTED TITANIUM STEM PROSTHESIS WAS DETECTED". TO DATE, THE PATIENT HAS NOT BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636825 HIP STEM GENERIC HIP STEM PRODUCT KWY ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other