BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4213430 · Received October 24, 2014

    Report

    Report Number
    3004105610-2014-00039
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    PMA / PMN Number
    K121056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION REGARDING THE SUSPECT MEDICAL DEVICE IS BEING REQUESTED. THE INVESTIGATION IS ON-GOING AND A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    STANMORE'S INVESTIGATION REVEALED THAT THE CUSTOMER HAD REQUESTED DELIVERY OF COMPONENTS FOR METS PROXIMAL FEMUR SURGERY. UPON DELIVERY THE SURGEON REALISED THAT THE TROCHANTER WAS MISSING AND CONTACTED STANMORE IMPLANTS. THIS ITEM WAS IMMEDIATELY DISPATCHED TO THE SURGEON. A TROCHANTER PLATE WAS ALSO MISSING BUT THIS WAS NOT NOTICED BY THE SURGEON UNTIL THE SURGERY. SINCE THIS COMPLAINT THE PROCEDURES (QF135 VERSION 2) HAVE BEEN UPDATED. THIS QUALITY INSPECTION RECORD CONTAINS A CHECKLIST AND THIS CHECKLIST MUST CHECKED BY THE DESIGN TEAM BEFORE THE KIT IS RELEASED. IT IS THE RESPONSIBILITY OF THE QUALITY DEPARTMENT TO CHECK BATCH RECORDS AND PERFORM A VISUAL CHECK ON THE IMPLANTS AND INSTRUMENTS PRIOR TO SHIPMENT. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE IMPLANTS WORLDWIDE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    THE SURGEON ORDERED A NUMBER OF METS COMPONENTS FOR A PROXIMAL TIBIAL REPLACEMENT PROCEDURE SCHEDULED FOR (B)(6), 2014. ON (B)(6), 2014 THE SURGEON NOTIFIED THE COMPANY THAT HE HAD RECEIVED THE ORDERED COMPONENTS, BUT NOTED THAT A "TROCHANTER, SPIKED HA COATED: LEFT, STANDARD" WAS MISSING FORM THE ORDER. THE SURGEON REQUESTED URGENT SHIPMENT OF THE PARTICULAR COMPONENT. THE COMPONENT WAS DELIVERED AND THE SURGEON PROCEEDED WITH THE PROCEDURE. DURING THE PROCEDURE, THE SURGEON DISCOVERED THAT THE TROCHANTER PLATE MSFPTE WAS NOT INCLUDED IN HIS ORDER. THE SURGERY WAS COMPLETED WITHOUT THE TROCHANTER PLATE.

    Description of Event or Problem · 1

    THE SURGEON ORDERED A NUMBER OF METS COMPONENTS FOR A PROXIMAL TIBIAL REPLACEMENT PROCEDURE SCHEDULED FOR (B)(6) 2014. ON (B)(6) 2014 THE SURGEON NOTIFIED THE COMPANY THAT HE HAD RECEIVED THE ORDERED COMPONENTS, BUT NOTED THAT A "TROCHANTER, SPIKED HA COATED: LEFT, STANDARD" WAS MISSING FORM THE ORDER. THE SURGEON REQUESTED URGENT SHIPMENT OF THE PARTICULAR COMPONENT. THE COMPONENT WAS DELIVERED AND THE SURGEON PROCEEDED WITH THE PROCEDURE. DURING THE PROCEDURE, THE SURGEON DISCOVERED THAT THE TROCHANTER PLATE MSFPTE WAS NOT INCLUDED IN HIS ORDER. THE SURGERY WAS COMPLETED WITHOUT THE TROCHANTER PLATE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00039 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678924 METS PROXIMAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other