BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4361017 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00073
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    May 17, 2012
    Report Date
    February 24, 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

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AN NO NON-CONFORMANCES WERE IDENTIFIED. 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 (K121029).

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS HAD A CHRONIC REACTION TO METAL AS MEDICAL RECORDS INDICATE THAT INFECTION HAD BEEN RULED OUT. THE IMPLANT WAS IN-SITU FOR 2 YEARS, AND WAS SUCCESSFULLY REVISED TO A DISTAL FEMUR. THERE WERE NO REPORTED COMPLICATIONS RESULTING FROM THE REVISION PROCEDURE. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2010 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO AN INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE ON(B)(6) 2010 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO AN INFECTION. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837983 CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT PROXIMAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. CRC1678

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention