BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4361018 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00072
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    April 9, 2012
    Report Date
    February 27, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AN NO NON-CONFORMANCES WERE IDENTIFIED. 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 CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR IMPLANT (K121056).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION TO A PROXIMAL FEMUR. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2009 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837627 CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT PROXIMAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME14657

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention