BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4308912 · Received December 1, 2014

    Report

    Report Number
    3004105610-2014-00053
    Event Type
    Injury
    Date Received
    December 1, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT IS CURRENTLY BEING DESIGNED AT STANMORE IMPLANTS WORLDWIDE LTD. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE PATIENT STATUS AND INFECTION. IT IS IMPORTANT TO NOTE THAT INFECTION IS A WELL RECOGNIZED COMPLICATION FOR PATIENTS UNDERGOING IMPLANTATION PROCEDURE. A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO METS MODULAR TOTAL FEMUR (K121055).

    Additional Manufacturer Narrative · 1

    INFECTION IS A PROCEDURE-RELATED ASPECT OF ARTHROPLASTY WITH SOMETIMES ADDITIONAL PATIENT-RELATED RISK FACTORS FOR INFECTION AND IS NOT NECESSARILY RELATED TO THE DEVICE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. REQUESTS WERE MADE FOR FURTHER INFORMATION IN RELATION TO THIS INCIDENT HOWEVER THE REQUESTED INFORMATION WAS NOT PROVIDED TO STANMORE IMPLANTS WORLDWIDE (SIW). FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS, PRODUCT RETURN, PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTIONS: COMMON DEVICE NAME WAS CORRECTED FROM PROSTHESIS, HIP, SEMI-CONSTRAINED TO LIMB SALVAGE SYSTEM. EXPIRY DATE CORRECTED FROM 04/14/2011 TO 03/15/2011.

    Description of Event or Problem · 1

    THE SURGEON CONTACTED THE COMPANY'S DISTRIBUTOR ON OCTOBER 30TH, 2014 TO REQUEST THAT STANMORE IMPLANTS DESIGN A CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT FOR HIS PATIENT WHO DEVELOPED AN INFECTION. THE ORIGINAL IMPLANT PROCEDURE OCCURRED IN (B)(6) IN (B)(6) 2010. THE SURGEON REPORTED THAT HE WILL PERFORM A TWO STAGE TREATMENT PROCEDURE. THE FIRST STAGE OF THE PROCEDURE INCLUDES REMOVAL OF BOTH THE FEMORAL AND TIBIAL COMPONENTS ONLY, AND THE USE OF AN ANTIBIOTIC SPACER CEMENT. THEN APPROXIMATELY THREE MONTHS LATER, THE SURGEON WILL PERFORM THE SECOND STAGE REVISION PROCEDURE USING THE CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT PROVIDED BY STANMORE IMPLANTS WORLDWIDE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-0053 ((B)(4)).

    Description of Event or Problem · 1

    THE SURGEON CONTACTED THE COMPANY'S DISTRIBUTOR ON (B)(6) 2014 TO REQUEST THAT STANMORE IMPLANTS DESIGN A CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT FOR HIS PATIENT WHO DEVELOPED AN INFECTION. THE ORIGINAL IMPLANT PROCEDURE OCCURRED IN THE (B)(6) IN (B)(6) 2010. THE SURGEON REPORTED THA THE WILL PERFORM A TWO STAGE TREATMENT PROCEDURE. THE FIRST STAGE OF THE PROCEDURE INCLUDES REMOVAL OF BOTH THE FEMORAL AND TIBIAL COMPONENTS ONLY, AND THE USE OF AN ANTIBIOTIC SPACER CEMENT. THEN APPROXIMATELY THREE MONTHS LATER, THE SURGEON WILL PERFORM THE SECOND STAGE REVISION PROCEDURE USING THE CUSTOMER DISTAL FEMUR REPLACEMENT IMPLANT PROVIDED BY STANMORE IMPLANTS WORLDWIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774832 CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME15216

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention