BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL TKR

    MDR report key: 4373013 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00192
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT HAS NOT BEEN RETURNED FOR EVAL, THEREFORE, A VISUAL INSPECTION HAS NOT BEEN POSSIBLE. A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE REPORTED PAIN. REQUESTS ARE BEING MADE FOR ADD'L INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM 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 IS BEING REVISED DUE TO PAIN. THERE IS NO ALLEGED MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851621 SPECIAL TKR TOTAL KNEE REPLACEMENT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME13971

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other