BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TOTAL KNEE REPLACEMENT

    MDR report key: 4834697 · Received June 5, 2015

    Report

    Report Number
    3004105610-2015-00049
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    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 DEVICE LABELLING AND IFU CONFIRMED THAT THE INFORMATION PROVIDED IS CORRECT. HOWEVER, A REVIEW OF THE CUSTOM DEVICE OPERATION DRAWING CONFIRMED AN INCORRECT RESECTION LEVEL FOR THE TYPE OF JOINT THAT WAS BEING IMPLANTED AND AN INCORRECT INDICATION THAT THE FEMORAL RESECTION MARKED WAS MEASURED FROM THE ¿MEDIAL FEMORAL CONDYLE¿, AS OPPOSED TO THE ¿LATERAL CONDYLE¿. THE INVESTIGATION CONFIRMED THAT THE INITIAL CUSTOM DESIGN WAS SUBSEQUENTLY MODIFIED; I.E. INSTEAD OF POLY CASE ROTATING HINGE JOINT, IT WOULD BE A ROTATING HINGE METAL CASE JOINT. THE DEVICE WAS SUBSEQUENTLY MANUFACTURED CORRECTLY WITH NO ABNORMALITIES OR DEVIATIONS IDENTIFIED WITHIN THE MANUFACTURING HISTORY RECORDS, HOWEVER, THE OPERATION DRAWING SUPPLIED WITH THE CUSTOM DEVICE WAS NOT UPDATED TO REFLECT THE RESECTION LEVEL ASSOCIATED WITH A ROTATING HINGE METAL CASE JOINT. THE INVESTIGATION ALSO IDENTIFIED THAT THE FEMORAL RESECTION WAS MARKED INCORRECTLY. THIS SHOULD HAVE BEEN IDENTIFIED DURING THE FINAL REVIEW OF THE DOCUMENTS PRIOR TO SHIPMENT. THIS WAS NOT IDENTIFIED AT THIS TIME. THE CUSTOMS DESIGN DEPARTMENT UNDERWENT AWARENESS TRAINING REGARDING THIS ISSUE ON JUNE 3 AND 4, 2015. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO THE METS SMILES TOTAL KNEE REPLACEMENT(K120992).

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REPRESENTATIVE THAT THE TIBIAL RESECTION LEVEL ON THE OPERATION DRAWING PROVIDED WITH THE CUSTOM DEVICE WAS INCORRECTLY MARKED AS 8MM INSTEAD OF 11MM. ALSO, THE OPERATION DRAWING SHOWED THE FEMORAL CONDYLE¿, AS OPPOSED TO THE ¿LATERAL CONDYLE¿ WHICH WAS NECESSARY DUE TO THIS PARTICULAR PATIENT¿S ANATOMY. THE SURGEON NOTICED THESE ISSUES WITH THE OPERATION DRAWING PRIOR TO MAKING ANY RESECTIONS TO THE BONE. ALTHOUGH THERE WAS A SLIGHT DELAY, THE SURGEON PERFORMED THE CORRECT CUTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366123 CUSTOM SMILES TOTAL KNEE REPLACEMENT TOTAL KNEE REPLACEMENT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME 19315 BME 19315

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR