BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER SL REVISION

    MDR report key: 4240333 · Received October 30, 2014

    Report

    Report Number
    9613350-2014-04069
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, WHERE LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE, AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED A WAGNER SL REVISION 14/190 ON THE LEFT SIDE ON (B)(6) 2014. THE SURGEON REAMED TO 14 MM ACCURATELY. WHEN IMPLANTING THE MATCHED SIZE 14 MM STEM, THE STEM WENT TOO FAR DOWN THE LEG CAUSING THE PT TO BE TOO SHORT. DUE TO THIS, THE PT WAS REVISED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695229 WAGNER SL REVISION WAGNER REVISIONAL FEMORAL HIP PROSTHESIS KWA ZIMMER GMBH 2696309

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R