BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL FEMUR METS

    MDR report key: 6092003 · Received November 10, 2016

    Report

    Report Number
    3004105610-2016-00104
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    PMA / PMN Number
    K121056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON RECEIPT OF THE ORDER THE SPECIFIC REQUIREMENTS WERE CONFIRMED BY CUSTOMER SERVICES BY PHONE. THE CUSTOMER SERVICE REPRESENTATIVE ENQUIRED WHICH TRIAL HEADS WERE REQUIRED. PRIOR TO DISPATCH THE TERRITORY MANAGER WAS NOTIFIED BY CUSTOMER SERVICES THAT, DUE TO BACK ORDERS THE ABOVE ITEMS WOULD NOT BE AVAILABLE. SIW DID NOT COMMUNICATE TO THE SURGEON THAT THE BACK ORDERED ITEMS WOULD NOT BE AVAILABLE OR CONFIRM WITH THE SURGEON THAT THE KIT BEING DISPATCHED WITHOUT THESE ITEMS WOULD BE SUITABLE FOR THE PLANNED SURGERY. ON INITIAL RECEIPT OF THE REPORTED EVENT, THE EVENT DESCRIPTION WAS REVIEWED AND WITH THE LIMITED INFORMATION AVAILABLE AT THAT TIME, A DECISION WAS MADE TO REPORT THE EVENT. HOWEVER ON COMPLETION OF THE INVESTIGATION INTO THE REPORTED EVENT IT CAN NOW BE CONCLUDED THAT THE INCIDENT DOES NOT MEET THE THREE BASIC REPORTING CRITERIA REFERENCED IN 21 CFR PART 803 AS A MARKETED DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR A MARKETED DEVICE HAS NOT MALFUNCTIONED WHERE THE MALFUNCTION OF THE DEVICE OR A SIMILAR MARKETED DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE SURGERY WAS COMPLETED SUCCESSFULLY. AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. NCR 060 HAS BEEN RAISED TO ADDRESS THIS EVENT FURTHER. A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BOOKING WAS RECEIVED FROM THE HOSPITAL REQUESTING THE METS PF KIT TOGETHER WITH A RANGE OF FEMORAL HEAD OPTIONS. THE KIT WAS DISPATCHED WITHOUT THE 36MM HEADS AND A TROCHANTER PLATE. THE SURGEON IDEALLY WANTED TO USE BOTH THESE ITEMS AND SO WAS UNABLE TO DO SO. HE MODIFIED THE OPERATION AND USED AN ALTERNATIVE MODULAR HEAD (32MM). INSTEAD OF THE TROCHANTER PLATE HE USED HEAVY GAUGE SUTURE MATERIAL TO ATTACH THE TROCHANTER TO THE PROSTHESIS. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00104 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BOOKING WAS RECEIVED FROM THE HOSPITAL REQUESTING THE METS PF KIT TOGETHER WITH A RANGE OF FEMORAL HEAD OPTIONS. THE KIT WAS DISPATCHED WITHOUT THE 36MM HEADS AND A TROCHANTER PLATE. THE SURGEON IDEALLY WANTED TO USE BOTH THESE ITEMS AND SO WAS UNABLE TO DO SO. HE MODIFIED THE OPERATION AND USED A ALTERNATIVE MODULAR HEAD (32MM). INSTEAD OF THE TROCHANTER PLATE HE USED HEAVY GAUGE SUTURE MATERIAL TO ATTACH THE TROCHANTER TO THE PROSTHESIS. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745166 PROXIMAL FEMUR METS LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD CRC PF4515

    Patients

    Seq Age Sex Outcome Treatment
    1 Other