BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TKR REPLACEMENT IMPLANT

    MDR report key: 4156382 · Received October 9, 2014

    Report

    Report Number
    3004105610-2014-00026
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 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

    THE COMPLAINT INVESTIGATION CONCLUDED THAT THIS IS AN ISOLATED INCIDENT INVOLVING A MISCOMMUNICATION BETWEEN THE SURGEON AND THE COMPANY REGARDING THE CUSTOM DEVICE ORDER. MORE SPECIFICALLY, IN THE CUSTOM DEVICE ORDER RECEIVED VIA FACSIMILE FROM THE HEALTHCARE FACILITY ON (B)(6) 2014, THE SURGEON BELIEVED THAT HE HAD ORDERED A CUSTOM DESIGN FOR A SPECIAL METAL CASE TIBIAL COMPONENT, ALONG WITH A STANDARD OFF-THE SHELF DEVICE (I.E., ALONG WITH A STANDARD OFF-THE SHELF DEVICE COMMUNICATION WAS NOT INTERPRETED BY THE COMPANY'S DESIGNER IN THE SAME MANNER. THE OPERATION DRAWING APPROVED BY THE SURGEON CONTAINED A NOTE: TO BE USED WITH THE METS TKR SYSTEM, USE MKT/SC STANDARD FOR TIBIAL COMPONENT. THUS THE COMPANY INTENTIONALLY DID NOT PROVIDE THE OFF-THE-SHELF METS TIBIAL COMPONENT, ALONG WITH THE CUSTOM DEVICE, BASED UPON ITS INTERPRETATION OF THE ORDER RECEIVED, AS WELL AS THE CUSTOM DEVICE DESIGN APPROVED BY THE SURGEON AND THE DEVICE DELIVERY NOTICE. PLEASE NOTE THAT THIS CUSTOM AN METS DEVICE COMBINATION IS SIMILAR TO METS SMILES TOTAL KNEE REPLACEMENT APPROVED UNDER K120992.

    Description of Event or Problem · 1

    DURING A (B)(6) 2014 SURGICAL PROCEDURE, THE COMPANY SALES REPRESENTATIVE REPORTED THAT THE SURGEON ADVISED THAT HE EXPECTED THAT THE CUSTOM METAL CASING DEVICE WOULD ALSO INCLUDE AN OFF-THE SHELF METS SMILES STANDARD TIBIAL COMPONENT. SINCE THE TIBIAL COMPONENT WAS NOT PROVIDED, THE THEATER STAFF OPENED AND USED THE SAME OFF-THE-SHELF METS SMILES TIBIAL COMPONENT THAT THE SURGEON HAD EXPECTED TO RECEIVE WITH THE CUSTOM CASING DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634016 CUSTOM SMILES TKR REPLACEMENT IMPLANT TOTAL KNEE REPLACEMENT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME18716 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR