BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL FEMUR

    MDR report key: 4361037 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00093
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO NON-CONFORMITIES IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR EVALUATION - INVESTIGATION INCONCLUSIVE. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS DEVICE IS SIMILAR TO THE METS MODULAR DISTAL FEMUR IMPLANT - K121056.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION. 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

    THE SURGEON HAS REQUESTED A SILVER COATED/TREATED CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT FOR A REVISION PROCEDURE ON AN EXISTING CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT THAT WAS ORIGINALLY IMPLANTED IN (B)(6) 1997. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON HAS REQUESTED A SILVER COATED/TREATED CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT FOR A REVISION PROCEDURE ON AN EXISTING CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT THAT WAS ORIGINALLY IMPLANTED IN (B)(6) 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837676 PROXIMAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME4566

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R