BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PROXIMAL FEMUR IMPLANT (MINIMALLY INVASIVE GROWER)

    MDR report key: 4411836 · Received January 7, 2015

    Report

    Report Number
    3004105610-2015-00001
    Event Type
    Injury
    Date Received
    January 7, 2015
    Date of Event
    December 4, 2014
    Report Date
    December 9, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS COMPLETED WITHOUT THE MISSING ALLEN KEY, IT WAS REQUIRED TO ASSESS THE EXTENSION MECHANISM OF THE NON-INVASIVE GROWER BEFORE AND DURING IMPLANTATION. THE INVESTIGATION IS ON-GOING AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. NOTE: THIS CUSTOM DEVICE IS SIMILAR TO METS MODULAR PROXIMAL FEMUR (K121056).

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE: REGARDING THE SURGEON'S COMMENT ABOUT A LATE DELIVERY OF THE TRIAL FEMORAL HEADS, WHILE THERE WAS A 24 HOUR DELAY IN SHIPMENT OF THESE HEADS, THE PROCEDURE OCCURRED ON SCHEDULE ON (B)(6) 2014. MORE SPECIFICALLY, THE PROPOSED DISPATCH DATE OF THE TRIAL HEADS WAS SCHEDULED TO BE (B)(6) 2014, ALTHOUGH IT WAS LATER CHANGED TO (B)(6) 2014. HOWEVER, THE TRIAL HEADS ARRIVED THAT SAME DAY ((B)(6) 2015 AT APPROXIMATELY 6PM) THEREBY ALLOWING THE TRIAL HEADS TO BE STERILISED AND READY FOR THE (B)(6) 2014 SURGERY. MISSING INSTRUMENT: THIS CUSTOM PROXIMAL FEMUR DEVICE REQUIRED THAT TWO ALLEN KEYS ALSO BE PROVIDED TO BE USED DURING THE PROCEDURE. THIS CUSTOM DEVICE PATIENT FILE CONFIRMED THAT A 2MM AND A 4MM ALLEN KEY WERE TO BE PROVIDED WITH THE PROSTHESIS. BOTH INSTRUMENTS ARE NOTED ON THE REQUEST FORM SUBMITTED BY THE SURGEON, AND ARE ALSO DESCRIBED ON THE CUSTOM DEVICE OPERATION DRAWING PROVIDED WITH THE DEVICE. AT THE TIME, THE ALLEN KEYS WERE SHIPPED ON A SEPARATE ORDER, AND IT IS POSSIBLE THAT THIS ORDER WAS NOT PICKED UP WHEN THE DEVICE WAS PACKAGED. THIS PROCESS HAS RECENTLY BEEN UPDATED; THERE IS ONE ORDER PER DEVICE WHICH INCLUDES ALL COMPONENTS AND INSTRUMENTS IDENTIFIED ON THE BILL OF MATERIALS. ADDITIONALLY, THE PROCESSING OF EACH ORDER NOW INCLUDES 3 INTERNAL CHECKS PRIOR TO THE ORDER BEING ISSUED. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN BY THE PHYSICIAN THAT THE DEVICE AND THE TRIAL FEMORAL HEADS WERE DELIVERED LATE FOR THE SURGERY. ADDITIONALLY, ALLEN KEYS WERE NOT INCLUDED WITH THE DEVICE DELIVERY. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-0001 ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED IN BY THE PHYSICIAN THAT THE DEVICE AND THE TRIAL FEMORAL HEADS WERE DELIVERED LATE FOR THE SURGERY. ADDITIONALLY, ALLEN KEYS WERE NOT INCLUDED WITH THE DEVICE DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10548 CUSTOM PROXIMAL FEMUR IMPLANT (MINIMALLY INVASIVE GROWER) LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD PIN 19072 PIN 19072

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR