BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4898335 · Received July 1, 2015

    Report

    Report Number
    3004105610-2015-00059
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING HISTORY RECORDS HAVE BEEN REVIEWED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED WITHIN SPEC WITH NO ABNORMALITIES OR DEVIATIONS. THIS CUSTOM ORDER WAS FOR A NON-STERILE DEVICE. A REVIEW OF THE DELIVERY NOTE ACCOMPANYING THE DEVICE CONFIRMED THAT IT INCORRECTLY SPECIFIED THAT THE CUSTOM DEVICE WAS STERILE AND THAT NO IRRADIATION WAS REQUIRED AS PER THE REPORTED COMPLAINT. HOWEVER, THE CUSTOM DEVICE WAS PROVIDED AS ORDERED (NON-STERILE) AND CORRECTLY LABELED AS NON-STERILE. THE DELIVERY NOTE IS GENERATED BY CUSTOMER SERVICES AND IS REVIEWED AND SIGNED BY A MEMBER OF THE DESIGN TEAM. BOTH TEAMS HAVE UNDERGONE AWARENESS TRAINING OF THE COMPLAINT. A REVIEW OF THE COMPLAINTS HISTORY FOR THE PREVIOUS 24 MONTHS IDENTIFIES NO SIMILAR REPORTED COMPLAINTS. 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 TO THE COMPANY SALES REPRESENTATIVE THAT THE DELIVERY ADVICE NOTICE STATED THAT THE DEVICE WAS STERILE AND NO IRRADIATION WAS REQUIRED. HOWEVER, THE CUSTOM DEVICE WAS PROVIDED NON-STERILE AS ORDERED. THE OUTER PLASTIC WRAPPING ON THE DEVICE CORRECTLY IDENTIFIED THE DEVICE AS NON-STERILE. THE THEATRE STORES TEAM IDENTIFIED THIS PRIOR TO THE DEVICE BEING SENT TO THE THEATRE. THE DEVICE UNDERWENT THE HOSPITAL'S OFF-SIRE STERILIZATION PROCESS AND WAS AVAILABLE FOR THE SCHEDULED PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426383 CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT LIMB SPARING SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD. BME 19481 BME 19481

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other