BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER SL REVISION, L190 MM

    MDR report key: 3233909 · Received July 16, 2013

    Report

    Report Number
    9613350-2013-01730
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    January 9, 2012
    Report Date
    July 8, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, AN UPDATED REPORT WILL BE SUBMITTED WHEN ADD'L INFO OR THE DEVICE IS RECEIVED AND INVESTIGATED. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A WAGNER SL REVISION 16/190, RIGHT SIDE, ON (B)(6) 2012. THE PT HAD HIP RELATED COMPLICATION ON OPERATIVE HIP. THE FEMORAL IMPLANT WAS LOOSENING. ON (B)(6) 2013, THE PT UNDERWENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330276 WAGNER SL REVISION, L190 MM WAGNER REVISIONAL FEMORAL HIP PROSTHESIS KWA ZIMMER, INC. 2616221

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R