BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT

    MDR report key: 4843691 · Received June 12, 2015

    Report

    Report Number
    3004105610-2015-00051
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG HISTORY RECORDS CONFIRMS THAT THE DEVICE WAS MFG TO SPEC WITH NO ABNORMALITIES OR DEVIATIONS. THE PT FILE NOTED THAT IN 2000, AN ALLERGY TO COBALT WAS IDENTIFIED. THUS THE MFG OF THE CURRENTLY IMPLANTED DEVICE WAS CARRIED OUT WITH STAINLESS STEEL, INSTEAD OF COBALT. THE SURGEON SUSPECTS THAT THERE MAY SOME LOOSENING OF THE DEVICE IMPLANTED 15 YEARS AGO, BUT AT THIS POINT, HE IS UNCERTAIN AS TO THE CAUSE OF THE CURRENT ISSUE. A REVISION PROCEDURE HAS BEEN SCHEDULED FOR (B)(6) 2015. ADD'L INFO AND THE RETURN OF THE EXPLANTED DEVICE HAS BEEN REQUESTED A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD LONG TERM, CHRONIC REACTIONS AND ALLERGIES TO METAL. THE 15 YEAR OLD IMPLANT WAS REPLACED BY A TITANIUM DISTAL FEMUR ON (B)(6) 2015. THE EXPLANTED DEVICE WAS NOT RETURNED FOR EVALUATION. THERE ARE NO REPORTED COMPLICATIONS RESULTING FROM THE REVISION PROCEDURE. THE COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    THE SURGEON HAS REQUESTED A NEW DISTAL FEMORAL REPLACEMENT DEVICE TO CARRY OUT A REVISION PROCEDURE. THE PT IS REPORTING INCREASING PAIN IN HER THIGH A DIFFICULTY WALKING. A SCAN AND BIOPSY IDENTIFIED METALLOSIS AT THE TIP OF THE STEM IN THE UPPER FEMUR AND SUSPECTED LOOSENING. THE SURGEON REPORTS NO EVIDENCE OF INFECTION. THE PT HAS A COBALT ALLERGY AND THE ORIGINAL PROSTHESIS WAS MFG FROM STAINLESS STEEL.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00051 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383930 CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. CME 7147 BME 7147

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other