BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TKR IMPLANT

    MDR report key: 4373364 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00118
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    August 17, 2012
    Report Date
    August 17, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE A VISUAL INSPECTION HAS NOT BEEN POSSIBLE. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. REQUESTS ARE BEING MADE FOR ADDITIONAL INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. 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 PT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2012 AND SUBSEQUENTLY REPORTED A FRACTURE OF THE TIBIAL BEARING. NO REPLACEMENT IMPLANT WAS REQUESTED FROM STANMORE FOR A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847140 CUSTOM SMILES TKR IMPLANT TOTAL KNEE REPLACEMENT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME17047

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention