BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOMER PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4377441 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00077
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    August 4, 2012
    Report Date
    August 4, 2012
    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

    THE MANUFACTURING RECORDS WERE REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED , THEREFORE A VISUAL INSPECTION HAS NOT BEEN POSSIBLE. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. REQUESTS ARE BEING MADE FOR ADDITIONAL 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 PROXIMAL FEMUR IMPLANT (K121056).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT PATIENT UNDERWENT A PROXIMAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2011 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838059 CUSTOMER PROXIMAL FEMUR REPLACEMENT IMPLANT PROXIMAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME16469

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R