BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT

    MDR report key: 3954765 · Received July 18, 2014

    Report

    Report Number
    3004105610-2014-00002
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS UNDERGONE SUCCESSFUL REVISION SURGERY FOR A DISTAL FEMUR. THE CAUSE OF THE REVISION HAS BEEN ATTRIBUTED TO PAIN REQUIRING THE REVISION. THE REPORTED PAIN AND DISCOMFORT COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY, ACTIVITY LEVELS, DISEASE PROGRESSION AND/OR SURGICAL FACTORS OR PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. THERE WERE NO REPORTED COMPLICATIONS RESULTING FROM THE REVISION SURGERY. THIS COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS IMPLANTED WITH A CUSTOM EXTRA SMALL METS SMILES KNEE. OUR RECORDS INDICATE THAT THE PATIENT HAD A REVISION IN 1999. AS THE PATIENT IS ENCOUNTERING DISCOMFORT, THE SURGEON IS CONTEMPLATING FURTHER REVISION. THE COMPANY'S DESIGN DEPARTMENT REVIEWED THE PATIENT'S RECENT X-RAYS AND HAVE SUGGESTED THAT THE PATIENT UNDERGO A TIBIAL REVISION WITH A SMALL METS SMILES KNEE. THE PHYSICIAN IS CURRENTLY REVIEWING THE SUGGESTED DESIGN PROPOSAL. A SUPPLEMENTAL WILL BE PROVIDED UPON RECEIPT OF FOLLOW-UP INFORMATION FROM THE FACILITY.

    Description of Event or Problem · 1

    IN AN EMAIL DATED (B)(6) 2014, THE SALES AGENT CONTACTED THE COMPANY'S DESIGN OFFICE AS REQUESTED BY THE CLINICIAN TO OBTAIN OPTIONS FOR A PLANNED REVISION OF THE TIBIAL COMPONENT ON A DISTAL FEMORAL CASE 1ST DONE ON (B)(6) 1991. IT WAS FURTHER NOTED THAT THE PATIENT HAS A LONG STEM METAL TIBIA COMPONENT THAT IS CAUSING SORENESS AND NEEDS REPLACING WITH EITHER ANOTHER METAL OR EVEN AN ALL POLY COMPONENT.

    Description of Event or Problem · 1

    IN AN EMAIL DATED (B)(6) 2014, THE SALES AGENT CONTACTED THE COMPANY'S DESIGN OFFICE AS REQUESTED BY THE CLINICIAN, TO OBTAIN OPTIONS FOR A PLANNED REVISION OF A TIBIAL COMPONENT ON A DISTAL FEMUR CASE FIRST DONE ON (B)(6) 1991. IT WAS FURTHER NOTED THAT THE PATIENT HAS A LONG STEM METAL TIBIA COMPONENT THAT IS CAUSING SORENESS AND NEEDS REPLACING WITH EITHER ANOTHER METAL OR EVEN AN ALL POLY COMPONENT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-002 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422536 CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME6616 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other