BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TKR

    MDR report key: 4373450 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00164
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO THE METS SMILES TOTAL KNEE REPLACEMENT (K120992).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT PRIOR TO THE PROCEDURE, IT WAS IDENTIFIED THAT THE EXTRA SMALL COMPONENTS FOR THE PATIENT. ALL COMPONENTS WERE AVAILABLE FOR THE STOCK HELD AT THE HOSPITAL, THE PATIENT'S PROCEDURE WAS POSTPONED UNTIL LATER IN THE DAY TO ALLOW TIME TO PREPARE AN EXTRA SMALL AXLE FOR THE PROCEDURE, HOWEVER, THIS WAS NOT PREPARED IN TIME FOR THE PROCEDURE, SO THE ORIGINAL AXLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847332 CUSTOM SMILES TKR TOTAL KNEE REPLACEMENT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME18820

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R