BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WAGNER CONE PROSTHESIS HIP STEM

    MDR report key: 3925660 · Received June 17, 2014

    Report

    Report Number
    9613350-2014-03615
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    February 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    ZIMMER RECEIVED ON (B)(6) 2014 FROM (B)(6) A USER REPORT REGARDING A BREAKAGE OF A WAGNER CONE PROSTHESIS. THE USER REPORT ((B)(6)) STATES: "A BREAKAGE OF A WAGNER CONE PROSTHESIS HAS OCCURRED. IT IS REPORTED SINCE 3 WEEKS PT PRESENTED WITH PAIN IN THE RIGHT HIP, PT CANNOT REMEMBER OF HAVING A TRAUMA. A REVISION SURGERY HAS BEEN PERFORMED TO CHANGE THE PROSTHESIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356447 UNKNOWN WAGNER CONE PROSTHESIS HIP STEM UNK WAGNER CONE PROSTHESIS HIP STEM KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R