BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TKR REPLACEMENT IMPLANT

    MDR report key: 4361022 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00070
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    February 27, 2012
    Report Date
    February 16, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. 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).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A SUCCESSFUL REVISION OF A SPACER. THIS REVISION IS THE SECOND STAGE OF A TWO STAGE TREATMENT. THE REPORTED CAUSE OF THE REVISION IS DUE TO INFECTION. THERE IS NO INDICATION AT THIS TIME THAT THE REPORTED INFECTION WAS ATTRIBUTED TO THE DEVICE. INFECTION IS A PROCEDURE-RELATED ASPECT OF ARTHROPLASTY WITH SOMETIMES ADDITIONAL PATIENT-RELATED RISK FACTORS FOR INFECTION. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. THE COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2010 AND SUBSEQUENTLY WAS REVISED IN (B)(6) 2012 DUE TO INFECTION. REF: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2010 AND SUBSEQUENTLY WAS REVISED IN (B)(6) 2012 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837736 CUSTOM SMILES TKR REPLACEMENT IMPLANT TOTAL KNEE REPLACEMENT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME15603

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention