BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TKR REPLACEMENT IMPLANT

    MDR report key: 4373368 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00135
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    February 26, 2013
    Report Date
    October 10, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K120992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION SURGERY FOR THE REPLACEMENT OF A COMPETITOR'S TKR. THE SURGERY WAS REQUIRED DUE TO A PATIENT INFECTION. THIS DEVICE WAS USED AS A SPACER AS A TREATMENT FOR INFECTION OF A FAILED TKR (COMPETITOR PRODUCT) AND WAS IMPLANTED TEMPORARILY. THIS REVISION SURGERY WAS COMPLETED WITH NO REPORTED COMPLICATIONS. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS DEVICE WAS IMPLANTED AS A SPACER USED WHILST TREATING THE PT FOR AN INFECTION. IT WAS INTENDED TO BE REVISED ONCE THE INFECTION HAD CLEARED. THERE WAS NO INDICATION OF ANY FAILURE OR MALFUNCTION OF THE DEVICE. PLEASE NOTE THAT THIS CUSTOMER IMPLANT IS SIMILAR TO THE METS SMILES TOTAL KNEE REPLACEMENT (K120992).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A REVISION PROCEDURE TO REMOVE A COMPETITORS DEVICE DUE TO INFECTION ON (B)(6) 2012. THIS DEVICE WAS USED AS A SPACER AND REVISED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE A COMPETITORS DEVICE DUE TO INFECTION ON (B)(6) 2012. THIS DEVICE WAS USED AS A SPACER AND REVISED ON (B)(6) 2013. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00135 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847316 CUSTOM SMILES TKR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME17316

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other