BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METS DISTAL FEMUR IMPLANT

    MDR report key: 4092400 · Received September 4, 2014

    Report

    Report Number
    3004105610-2014-00023
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. ADDITIONAL PT SPECIFIC INFO REGARDING THE COMPLAINT HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED THE COMPANY REP ON (B)(6) 2014 TO REPORT THAT A PT WITH A METS DISTAL FEMUR IMPLANTED APPROXIMATELY THREE YEARS AGO HAD UNDERGONE A DIAR (DEBRIDEMENT, ANTIBIOTIC AND IMPLANT RETENTION) PROCEDURE AS A RESULT OF A GROSS INFECTION. ALL CEMENTED PARTS/ PLASTICS WERE REPLACED WHILE KEEPING THE ORIGINAL IMPLANT IN SITU. THE EXPLANTED PARTS WERE SENT TO THE FACILITY'S MICROBIOLOGY LAB FOR CULTURING. THE SURGEON SUBSEQUENTLY ADVISED THAT THE PT'S INFECTION WAS CHARACTERIZED AS PSEUDONYMOUS AND TWO TYPES OF STAPHYLOCOCCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542174 METS DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization