BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK- NON- STANMORE HIP REPLACEMENT IMPLANT

    MDR report key: 4870767 · Received June 25, 2015

    Report

    Report Number
    3004105610-2015-00058
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    January 1, 2015
    Report Date
    May 26, 2015
    Manufacturer
    UNKNOWN
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL IMPLANTATION OF A STANMORE IMPLANTS PROXIMAL FEMUR REPLACEMENT IMPLANT. THE FAILED DEVICE IN SITU WAS A NON-STANMORE IMPLANTS DEVICE. THERE WERE NO REPORTED COMPLICATIONS RESULTING FROM THE REVISION PROCEDURE. THE COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY RECORDS HAS BEEN CARRIED OUT AND CONFIRM THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE PATIENT'S RADIOGRAPHS HAS BEEN CARRIED OUT. THE REPORTED COMPLAINT HAS NOT BEEN CONFIRMED AS THE RADIOGRAPHS DO NOT SHOW ANY OBVIOUS FAILURE OF THE DEVICE. ADDITIONAL INFORMATION REGARDING THE PATIENT AND THE REPORTED EVENT HAVE BEEN REQUESTED. THE COMPANY HAS ALSO REQUESTED RETURN OF THE EXPLANTED DEVICE FOR EVALUATION FOLLOWING THE (B)(6) 2015 REVISION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR IMPLANT (K121056).

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00058 ((B)(4)).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE SURGEON SUBMITTED AN ORDER FOR A NEW CUSTOM FEMUR REPLACEMENT IMPLANT FOR A REPORTED FAILED HIP PROSTHESIS. THE REVISION PROCEDURE IS PLANNED FOR (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411550 UNK- NON- STANMORE HIP REPLACEMENT IMPLANT LIMB SPARING SYSTEM KRO UNKNOWN UNKOWN UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other