BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR SMILES SMALL

    MDR report key: 6202458 · Received December 23, 2016

    Report

    Report Number
    3004105610-2016-00142
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    December 12, 2016
    Report Date
    March 13, 2017
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FOR THE REVISION SURGERY HAS BEEN DISPATCHED BUT THE DATE FOR THE REVISION SURGERY IS NOT KNOWN AT THIS TIME. A REVIEW OF THE DEVICE MANUFACTURING HISTORY RECORDS CONFIRMS THAT NO NON-CONFORMING PRODUCT WAS RELEASED. LOT NUMBER OF THE DEVICE WAS CORRECTED FROM PIN 14398 TO PIN 11528 AND EXPIRY DATE WAS UPDATED TO 12/16/2005 FOR PIN 11528. DATE IMPLANTED WAS CORRECTED TO (B)(6) 2005 FOR PIN 11528. MANUFACTURE DATE WAS CORRECTED TO 06/16/2005 FOR PIN 11528.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. UNKNOWN IF THE DEVICE WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND LOOSENING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND LOOSENING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852023 DISTAL FEMUR SMILES SMALL LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE PIN 14398 PIN 11528

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention