BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT

    MDR report key: 4373408 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00138
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    April 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A SUCCESSFUL REVISION OF A CUSTOM DISTAL FEMUR REPLACEMENT. THE ORIGINAL DEVICE WAS IMPLANTED 5 YEARS PRIOR TO AN INITIAL INFECTION IN 2008. THERE IS NO INDICATION AT THIS TIME THAT THE REPORTED INFECTION IS 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 RE-OPENED. THIS COMPLAINT IS BEING CLOSED, TRACKED AND TRENDED. COMMON DEVICE NAME/PRODUCT CODE WAS CORRECTED FROM "CUSTOM DISTAL FEMUR" TO "LIMB SALVAGE SYSTEM/KRO."

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND 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 ADD'L 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 DISTAL FEMUR (K121029).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2008 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2013 DUE TO AN INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2008 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2013 DUE TO AN INFECTION. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00138 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847159 CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME14190

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention